Flags with the logos of Danish drugmaker Novo Nordisk, maker of the blockbuster diabetes and weight-loss treatments Ozempic and Wegovy are pictures while the company presents the annual report at Novo Nordisk in Bagsvaerd, Denmark, on February 5, 2025.
Mads Claus Rasmussen | Afp | Getty Images
Novo Nordisk scored a huge legal victory that largely restricts compounding pharmacies from marketing or selling cheaper, unapproved versions of the drugmaker’s blockbuster weight loss drug Wegovy and diabetes treatment Ozempic.
A federal judge in Texas late Thursday rejected a bid by compounding pharmacies to keep making copies of Ozempic and Wegovy while a legal challenge over the shortage of those drugs unfolds. That came in response to a February lawsuit from a compounding trade group against the Food and Drug Administration’s determination that the active ingredient in those drugs, semaglutide, is no longer in shortage in the U.S.
Patients flocked to the cheaper copycats when Ozempic and Wegovy were in short supply over the last two years due to skyrocketing demand, or if they didn’t have insurance coverage for the costly treatments.
During FDA-declared shortages, pharmacists can legally make compounded versions of brand-name medications. Many telehealth companies, such as Hims & Hers, also offered those copycats. But drugmakers and some health experts have pushed back against the practice because the FDA does not approve compounded drugs, which are essentially custom-made copies prescribed by a doctor to meet a specific patient’s needs.
“We are pleased the court has rejected the compounders’ attempts to undermine FDA’s data-based decision that the shortage” of semaglutide is resolved, said Steve Benz, Novo Nordisk’s corporate vice president, legal and U.S. general counsel, in a statement.
“Patient safety remains a top priority for Novo Nordisk and the extensive nationwide legal actions we have taken to protect Americans from the health risks posed by illegitimate ‘semaglutide’ drugs are working,” he said, referring to the company’s more than 100 lawsuits against compounding pharmacies and other entities across 32 states.
On Thursday, U.S. District Judge Mark Pittman specifically denied the Outsourcing Facilities Association’s bid for a preliminary injunction that would have prevented the FDA from taking action against its members for making copies of semaglutide.
That decision upholds the FDA’s previous determination that the semaglutide shortage in the U.S. is over and means the FDA can now immediately go after so-called 503A pharmacies that are making compounded versions of semaglutide according to individual prescriptions for a specific patient.
Those pharmacies are largely regulated by states rather than the FDA.
The decision also means the FDA can start targeting federally regulated 503B pharmacies, which manufacture compounded drugs in bulk with or without prescriptions, after May 22. The agency’s actions can include product seizures and warning letters to pharmacies.
More CNBC health coverage
The decision on Thursday follows another win for Novo Nordisk. A different federal judge in Texas earlier this week ruled in favor of the drugmaker against a 503A pharmacy, MediOak Pharmacy, permanently prohibiting the business from marketing or selling compounded semaglutide.
Novo Nordisk and Eli Lilly have aggressively cracked down on compounding pharmacies over the last two years as they benefit from the soaring popularity of their weight loss and diabetes drugs.
Eli Lilly has gone through a similar legal process with tirzepatide, the active ingredient in its weight loss drug Zepbound and diabetes treatment Mounjaro. The FDA declared the U.S. shortage of tirzepatide over last year, prompting the same compounding trade group to sue the FDA over the drug.
In March, a federal judge denied the compounding group’s request for a preliminary injunction on the FDA’s enforcement against its members for making copies of Mounjaro and Zepbound. The compounding group has appealed.
The Hims app arranged on a smartphone in New York on Feb. 12, 2025.
Gabby Jones | Bloomberg | Getty Images
Hims & Hers Health shares closed up 5% on Tuesday after the company announced patients can access Eli Lilly‘s weight loss medication Zepbound and diabetes drug Mounjaro, as well as the generic injection liraglutide, through its platform.
Zepbound, Mounjaro and liraglutide are part of the class of weight loss medications called GLP-1s, which have exploded in popularity in recent years. Hims & Hers launched a weight loss program in late 2023, but its GLP-1 offerings have evolved as the company has contended with a volatile supply and regulatory environment.
Lilly’s weekly injections Zepbound and Mounjaro will cost patients $1,899 a month, according to the Hims & Hers website. The generic liraglutide will cost $299 a month, but it requires a daily injection and can be less effective than other GLP-1 medications.
“As we look ahead, we plan to continue to expand our weight loss offering to deliver an even more holistic, personalized experience,” Dr. Craig Primack, senior vice president of weight loss at Hims & Hers, wrote in a blog post.
A Lilly spokesperson said in a statement that the company has “no affiliation” with Hims & Hers and noted that Zepbound is available at lower costs for people who are insured for the product or for those who buy directly from the company.
In May, Hims & Hers started prescribing compounded semaglutide, the active ingredient in Novo Nordisk‘s GLP-1 weight loss medications Ozempic and Wegovy. The offering was immensely popular and helped generate more than $225 million in revenue for the company in 2024.
But compounded drugs can traditionally only be mass produced when the branded medications treatments are in shortage. The U.S. Food and Drug Administration announced in February that the shortage of semaglutide injections products had been resolved.
That meant Hims & Hers had to largely stop offering the compounded medications, though some consumers may still be able to access personalized doses if it’s clinically applicable.
During the company’s quarterly call with investors in February, Hims & Hers said its weight loss offerings will primarily consist of its oral medications and liraglutide. The company said it expects its weight loss offerings to generate at least $725 million in annual revenue, excluding contributions from compounded semaglutide.
But the company is still lobbying for compounded medications. A pop up on Hims & Hers’ website, which was viewed by CNBC, encourages users to “use your voice” and urge Congress and the FDA to preserve access to compounded treatments.
With Tuesday’s rally, Hims and Hers shares are up about 27% in 2025 after soaring 172% last year.
This week was supposed to mark the end of compounding pharmacies making copycat versions of Eli Lilly‘s weight-loss drug Zepbound and its diabetes drug Mounjaro. Online, it doesn’t look like much has changed.
Popular websites like Amble, EllieMD, Willow and Mochi Health are all still advertising versions of tirzepatide, the active ingredient in Zepbound. Some, like Ivim, have stopped taking new patients.
Mochi Health has no plans to stop, and neither do the four pharmacies it uses to supply patients with the medications, said Mochi CEO Myra Ahmad. The company uses a network of about 500 providers to write prescriptions for weight-loss drugs, including compounded versions. It’s betting that offering personalized versions of the drugs will keep the company out of the crosshairs.
“It can be different dosing schedules … some patients prefer to go up in dosage much more slowly,” Ahmad said. “Some patients like to mix a number of other medications into their compounded formulations, depending on the side effects that they’re having. Some patients have side effects with any additives and brand name formulations. Compounding really opens up the door for so much personalization.”
Amble, EllieMD and Willow didn’t respond to CNBC’s request for comment.
Compounding is where pharmacies mix ingredients of a drug to create a specialized version for specific patients. Say someone is allergic to a dye in a branded medication or needs a liquid form and the main manufacturer only sells capsules. In that case, the patient can turn to a compounded version.
When drugs are in shortage, they can be compounded in larger quantities to help fill the gap.
Copycat versions of Lilly’s Mounjaro and Zepbound and Novo Nordisk‘s Wegovy and Ozempic have been widely available in recent years because the U.S. Food and Drug Administration listed the brand versions as being in short supply.
That created a booming business for pharmacies compounding the highly popular class of weight loss and diabetes medications called GLP-1s.
But late last year, the FDA said all doses of Mounjaro and Zepbound were readily available and took the drug off its shortage list, spelling the end for mass compounding of the drug. After months of legal challenges, the FDA gave smaller pharmacies until early March to stop and larger pharmacies until this week before it started enforcing its rules.
The larger facilities aren’t allowed to compound tirzepatide at all anymore. Smaller ones aren’t supposed to make products that are essentially copies of a commercially available drug, a moniker with some wiggle room. The FDA sees essential copies as those that have a dosage within 10% of the commercially available drug or combine two or more commercially available drugs.
Mochi insists all of its prescriptions are personalized, including doses that differ from the standard Zepbound strengths. Other websites like EllieMD are advertising tirzepatide mixed with vitamin B12.
Scott Brunner, CEO of the Alliance for Pharmacy Compounding, said formulations or dosage strengths that aren’t commercially available aren’t considered a copy. However, combining two drugs into one — like adding vitamin B6 or B12 — would be considered a copy under a strict reading of FDA guidance.
“FDA guidance are pretty clear about what is and is not a copy,” Brunner said. “And I would say any compounding pharmacy or outsourcing facility that continues to prepare copies of tirzepatide injection after today are putting themselves in a certain amount of legal risks.”
John Herr, pharmacist and owner of Town & Country Compounding Pharmacy, stopped compounding tirzepatide earlier this month. He didn’t want to take the risk even though his 300 to 400 patients on it have been calling nonstop to complain about losing access.
Town & Country, based in Ramsey, New Jersey, was charging patients about $200 a month — about one-fifth the list price for Zepbound and less than half the price Lilly charges self-paying patients.
What happens next is an open question. Enforcing the ban on mass compounding of tirzepatide mostly falls to the FDA. The agency didn’t immediately respond to CNBC’s request for comment.
Lilly can try to sue companies that continue, but it hasn’t had much luck in the past. A Florida judge last year dismissed one of Lilly’s cases, saying the company was trying to enforce a law that only the FDA can.
Ahmad, the CEO of Mochi, said she isn’t worried about Lilly taking legal action against her providers. The way she sees it, they have established patient-physician relationships with the autonomy to decide how best to manage their patients.
The next two months will be informative. Mass compounding of semaglutide — the active ingredient in Novo Nordisk’s Ozempic and Wegovy — needs to stop by the end of May, according to the FDA.
Hims & Hers Health has already said it will stop selling commercially available doses of semaglutide when the time comes. Customers who have a personalized dosing regimen will be able to continue without any change, the company added.
Shares of Hims & Hers Health closed down 22% on Tuesday, a day after the telehealth company released fourth-quarter results that disappointed on gross margin and sparked concerns about the future of its weight loss business.
Hims & Hers reported $481 million in revenue for the quarter, up 95% from $246.6 million during the same period last year. Net income climbed to $26.01 million, or 11 cents per share, from $1.25 million, or 1 cent per share, a year prior.
But the company’s gross margin, or the profit left after accounting for the cost of goods sold, was 77%, disappointing analysts who were expecting 78.4%, according to StreetAccount.
In the company’s quarterly call with investors on Monday, Chief Financial Officer Yemi Okupe said the scaling of the company’s GLP-1 offering and its strategic pricing options were to blame.
Hims & Hers in May started prescribing compounded semaglutide, the active ingredient in Novo Nordisk‘s GLP-1 weight loss medications Ozempic and Wegovy. Compounded drugs can be produced when brand-name treatments are in shortage, but the U.S. Food and Drug Administration announced Friday that the shortage of semaglutide injection products has been resolved.
As a result, Hims & Hers said Monday that it will likely stop offering compounded semaglutide on its platform after its first quarter, though some consumers may still be able to access personalized doses if clinically applicable. The GLP-1 offering generated more than $225 million in revenue for the company in 2024.
“We will have to start notifying customers in the coming month or two that they will need to start looking for alternative options on the commercial dosing,” Hims & Hers CEO Andrew Dudum said on the call.
Going forward, the company said its weight loss offerings will primarily consist of its oral medications and the injectable medication liraglutide, which it plans to introduce on its platform this year.
Analysts at Morgan Stanley said in a note Tuesday that the company’s report was “a lot to digest.” They maintained their equal-weight rating on the stock and said they were surprised by the magnitude of the company’s 2025 guidance.
Hims & Hers said it expects between $2.3 billion and $2.4 billion in revenue this year. The company added that it expects its weight loss offerings to generate at least $725 million in revenue, excluding contributions from compounded semaglutide.
“We remain positive on the long-term opportunity, highlighting the company’s attractive platform and solid track record that differentiate it relative to digital health and DTC comps,” the Morgan Stanley analysts said.
Bank of America analysts said that while the company might have some success transitioning patients to its other weight loss offerings such as its oral medications, it will face a “significant execution risk” as supply of brand-name GLP-1s increases.
Additionally, the analysts said Hims & Hers’ competitors will likely shift marketing dollars back to other products for conditions such as erectile dysfunction and hair loss, which could put pressure on its advertising costs. They reiterated their underperform rating on the stock.
“Overall, we do not see upside to 2025 revenue guidance and think the beat and raise story is likely over in the near-term,” the Bank of America analysts wrote in a note Tuesday.
Citi analysts meanwhile said they think Hims & Hers’ revenue guidance is “aspirational,” as it would require “significant acceleration” in the use of its other weight loss products. They said they are less confident about the success of these offerings.
Even so, the analysts increased their price target on the stock to $27 from $25.
“We await a more compelling entry point and more details on growth ex-GLP-1s before we become more constructive,” they wrote in a Monday note.
— CNBC’s Michael Bloom contributed to this report.
Hims & Hers Health shares plunged 18% in extended trading on Monday after investors looked past better-than-expected revenue and earnings and focused instead on the disappointing gross margin.
Here’s how the company did, compared to analysts’ consensus estimates from LSEG:
Earnings per share: 11 cents vs. 10 cents expected
Revenue: $481 million vs. $470 millionexpected
Revenue at the telehealth company increased 95% in the fourth quarter from $246.6 million during the same period last year, according to a release.
However, the company’s gross margin, or the profit left after accounting for the cost of goods sold, was 77%, while analysts polled by StreetAccount were expecting 78.4%.
It is the second big stock drop for Hims & Hers in a matter of days. The shares tumbled 26% on Friday after the U.S. Food and Drug Administration announced that the shortage of semaglutide injection products has been resolved.
In May, Hims & Hers started prescribing compounded semaglutide, the active ingredient in Novo Nordisk‘s blockbuster GLP-1 medications Ozempic and Wegovy. The company was a breakout star within the digital health sector in 2024, in part because of the success of its popular new weight loss offering.
The company said its GLP-1 offering generated more than $225 million in revenue in 2024. The stock climbed about 200% for the year.
Compounded drugs are custom-made alternatives to brand-name drugs designed to meet a specific patient’s needs, and compounders are allowed to produce them when brand-name treatments are in shortage. The FDA said Friday that it will start taking action against compounders for violations in the next 60 to 90 days.
Hims & Hers said on the earnings call that as a result, compounded semaglutide will likely not be offered on the platform after the first quarter.
“We will have to start notifying customers in the coming month or two that they will need to start looking for alternative options on the commercial dosing,” Hims & Hers CEO Andrew Dudum said on the call. “I would suspect, just being very direct, that a lot of those patients will try to go into the open market and try to secure a branded option in some form factor.”
Some patients might still be able to access compounded semaglutide if it is clinically necessary, the company added.
The company’s weight loss offerings will primarily be composed of its oral medications and the generic medication liraglutide, which it plans to introduce on its platform this year. Excluding contributions from compounded semaglutide, Hims & Hers said it expects it weight loss offering will generate at least $725 million in revenue in 2025.
Hims & Hers also offers treatments for skin care, mental health, sexual health and hair care.
Revenue for non-GLP-1 products increased 43% to $1.2 billion for the full year, “meeting our previous 2025 revenue target a year early,” Chief Financial Officer Yemi Okupe said in a release.
“The success we are experiencing is a direct reflection of our improving ability to democratize access to high quality, personalized care across each of our specialties,” Okupe said.
Net income climbed to $26.01 million, or 11 cents per share, from $1.25 million, or 1 cent per share, a year prior. The company reported adjusted earnings of $54.1 million, meeting analysts’ estimates, according to StreetAccount.
For the first quarter, Hims & Hers expects to report revenue of $520 million to $540 million, while analysts were expecting $497 million. Adjusted earnings will be between $55 million and $65 million for the period, the company said.
Hims & Hers will host its quarterly call with investors at 5:00 p.m. ET.
— CNBC’s Brandon Gomez contributed to this report.
Shares of Hims & Hers Health closed down around 26% on Friday after the U.S. Food and Drug Administration announced that the shortage of semaglutide injection products has been resolved.
Semaglutide is the active ingredient in Novo Nordisk‘s blockbuster weight loss drug Wegovy and diabetes treatment Ozempic. Those medications are part of a class of drugs called GLP-1s, and demand for the treatments has exploded in recent years. As a result, digital health companies such as Hims & Hers have been prescribing compounded semaglutide as an alternative for patients who are navigating volatile supply hurdles and insurance obstacles.
Compounded drugs are custom-made alternatives to brand-name drugs designed to meet a specific patient’s needs, and compounders are allowed to produce them when brand-name treatments are in shortage. The FDA doesn’t review the safety and efficacy of compounded products.
Hims & Hers began offering compounded semaglutide to patients in May, and it owns compounding pharmacies that produce the medications.
Compounded medications are typically much cheaper than their branded counterparts. Hims & Hers sells compounded semaglutide for less than $200 per month, while Ozempic and Wegovy both cost around $1,000 per month without insurance.
The FDA said Friday that it will start taking action against compounders for violations in the next 60 to 90 days, depending on the type of facility, in order to “avoid unnecessary disruption to patient treatment.”
“Now that the FDA has determined the drug shortage for semaglutide has been resolved, we will continue to offer access to personalized treatments as allowed by law to meet patient needs,” Hims & Hers CEO Andrew Dudum posted Friday on X. “We’re also closely monitoring potential future shortages, as Novo Nordisk stated two weeks ago that it would continue to have ‘capacity limitations’ and ‘expected continued periodic supply constraints and related drug shortage notifications.’”
Him & Hers’ weight loss offerings have been a massive hit with investors. Shares of the company climbed more than 200% last year, and the stock is already up more than 100% this year despite Friday’s move.
Even before it added compounded GLP-1s to its portfolio, the company said in its 2023 fourth-quarter earnings call that it expects its weight loss program to bring in more than $100 million in revenue by the end of 2025.
Despite the turbulent regulatory landscape, Hims & Hers has showed no signs of slowing down.
On Friday, the company announced it has acquired a U.S.-based peptide facility that will “further verticalize the company’s long-term ability to deliver personalized medications.” Hims & Hers will explore advances across metabolic optimization, recovery science, biological resistances, cognitive performance and preventative health through the acquisition, the company said.
That move comes just days after Hims & Hers also bought Trybe Labs, the New Jersey-based at-home lab testing facility. Trybe Labs will allow Hims & Hers to perform at-home blood draws and more comprehensive pretreatment testing.
Hims & Hers did not disclose the terms of either deal.
Boxes of Ozempic and Wegovy made by Novo Nordisk are seen at a pharmacy.
Hollie Adams | Reuters
The long-running U.S. shortage of Novo Nordisk‘s blockbuster weight loss injection Wegovy and diabetes treatment Ozempic is resolved after more than two years, the U.S. Food and Drug Administration said Friday.
The FDA’s decision will threaten the ability of compounding pharmacies to make far cheaper, unbranded versions of the injections over the next few months. Many patients relied on unapproved versions of Wegovy and Ozempic since compounding pharmacies are allowed to make versions of branded medications in short supply.
Novo Nordisk’s stock closed about 5% higher on Friday. Meanwhile, shares of Hims & Hers, a telehealth company offering compounded Wegovy and Ozempic, fell more than 25%.
The active ingredient in both of Novo Nordisk’s injectable drugs, semaglutide, has been in shortage in the U.S. since 2022 after demand skyrocketed. That has forced Novo Nordisk and its rival Eli Lilly to invest heavily to expand their manufacturing footprints for their respective weight loss and diabetes drugs — and it may be paying off.
The FDA determined that Novo Nordisk’s supply and manufacturing capacity for semaglutide injections can now meet the current and projected demand in the U.S. Still, the agency noted that patients and prescribers may still see “intermittent and limited localized supply disruptions” as products move through the supply chain to pharmacies.
“We are pleased the FDA has declared that supply of the only real, FDA-approved semaglutide medicines is resolved,” Dave Moore, Novo Nordisk’s executive vice president of U.S. operations and global business development, said in a statement.
He added that “no one should have to compromise their health due to misinformation and reach for fake or illegitimate knockoff drugs that pose significant safety risks to patients.”
The FDA’s announcement comes just months after the agency declared the shortage of tirzepatide — the active ingredient in Eli Lilly’s weight loss injection Zepbound and diabetes counterpart Mounjaro — was over.
The FDA’s decision on Friday could better position Novo Nordisk to compete with Eli Lilly in the booming weight loss drug market, which some analysts say could be worth more than $150 billion annually after 2030.
Threat to compounded medications
The agency’s decision, based on a comprehensive analysis, essentially marks the end of a period where compounding pharmacies could make, distribute or dispense unapproved versions of semaglutide without facing repercussions for violations related to the treatment’s shortage status.
Compounding pharmacies must stop making compounded versions of semaglutide in the next 60 to 90 days, depending on the type of facility, the agency said. That transition period will likely give patients time to switch to the branded versions of the medications.
But, in compliance with FDA rules, compounders can still make alternative versions of the drugs if they modify doses, add other ingredients or change the method of giving the treatment to meet a specific patient’s needs.
Some patients rely on compounded versions because they do not have insurance coverage for Novo Nordisk’s drugs and cannot afford their hefty price tags of roughly $1,000 a month. While Ozempic is covered by most health plans, weight loss drugs such as Wegovy are not currently covered by Medicare and other insurance.
The New York Stock Exchange with a Hims & Hers Health banner is pictured in the Manhattan borough of New York City.
Carlo Allegri | Reuters
Hims & Hers Health announced Wednesday it has acquired New Jersey-based at-home lab testing facility Trybe Labs.
The deal will allow the telehealth company to offer at-home blood draws and more comprehensive pretreatment testing to its users.
“Access to richer data allows us to deepen the insights that providers can use on our platform to guide their clinical decisions for each individual patient,” said Dr. Patrick Carroll, Hims & Hers chief medical officer.
“At-home lab testing is one more exciting step towards elevating the personal, comprehensive care customers in this country should expect,” Dr. Carroll added.
Hims & Hers did not disclose terms of the deal, but said it funded it through cash on hand. The company told CNBC it will share pricing for the new testing options when the offering is made available to customers over the next year.
The acquisition by Hims & Hers will offer competition to blood-drawing services such as Labcorp and Quest Diagnostics.
The startup is expanding its services less than one year after it started offering compounded GLP-1 weight loss drugs. As Hims & Hers casts itself as a cheaper alternative to established companies, it recently took aim at the pharmaceutical industry in a Super Bowl ad, saying the industry is “priced for profits, not patients.”
“The health care that customers expect and deserve today is on-demand care with treatments designed specifically for them,” said Dr. Carroll.
On Friday, the company separately announced it has acquired a U.S.-based peptide facility in California as part of its latest expansion of that domestic supply chain.
“A lot of peptide demand is future facing innovation,” Andrew Dudum, Hims & Hers Health CEO told CNBC Friday following that announcement. “So many use cases have yet to be launched,” he added.
The acquisition follows previous purchases of drug manufacturing facilities in Ohio and Arizona over the last six years.
While Hims did not disclosure the international exposure of its supply chain, Dudum did emphasize this deal comes at a time when the Trump administration is cracking down on the broader pharmaceutical industry’s reliance on overseas production.
Peptide therapy has gained popularity in recent years, particularly within the fitness and wellness community. Secretary of Health and Human Services Robert F. Kennedy Jr. has vocalized support for the treatment as alternative medicine, saying it has been under “aggressive suppression” by the Food and Drug Administration like other alternatives like psychedelics, stem cells and raw milk.
However, the excitement surrounding peptide innovations have limited scientific evidence supporting their long-term benefits.
Dudum said the acquisition will allow his company to explore areas including recovery science, preventative health and rejuvenation.
“Peptide innovation is at the forefront of so many categories we’re excited to start offering,” said Dudum.
Trybe acquisition
Hims & Hers’ acquisition of Trybe Labs will add testing capabilities for LDL cholesterol, lipoprotein(a), cholesterol and apolipoprotein, the company said. It will also expand the company’s ability to offer access to care and treatments across a range of conditions including low testosterone and perimenopausal and menopausal support.
The Tasso+ device is a blood lancet that collects whole liquid blood samples.
Courtesy: Tasso Inc.
Hims & Hers users will be given a blood lancet provided by home diagnostic testing company Tasso. The lancet is a single-use device that collects whole liquid blood samples and is cleared for premarket use by the FDA.
Users attach the device to their upper arm and press a button that triggers the lancet to prick the skin and draw a small amount of blood collected in a microtube.
Providers on the platform will use the information collected as part of determining a treatment plan for patients.
Hims & Hers said it will use data from the blood work — with patient identities removed — to accelerate its development of artificial intelligence-powered health care.
Clarification: This story was updated to reflect that the new testing services will aid the company’s perimenopausal care.
A version of this article first appeared in CNBC’s Healthy Returns newsletter, which brings the latest health-care news straight to your inbox. Subscribe here to receive future editions.
Novo Nordisk‘s blockbuster diabetes drug Ozempic may also help people drink less alcohol.
That’s according to new government-funded research published in JAMA Psychiatry last week.
It was a small study of just 48 adults that lasted over two months, but it appears to be the first clinical trial confirming that so-called GLP-1 drugs could help reduce the risks of consuming too much alcohol. Multiple analyses of real-world data, along with studies in animals, have suggested that link.
The findings could be huge for those with alcohol-use disorder, which is when a person can’t stop drinking even when it puts their health and safety at risk. The condition affects almost 30 million people in the U.S., and encompasses what people generally refer to as alcohol abuse, alcohol dependence or alcoholism, according to the 2023 National Survey on Drug Use and Health.
Alcohol use accounts for 2.6 million deaths per year, and increases the risk of common diseases such as different cancers, the study authors wrote. There are three medications already approved for alcohol-use disorder, but the authors said only a small share of patients with the condition receive treatment.
The new data adds to growing evidence that GLP-1s, such as Ozempic and its weight loss counterpart Wegovy, can help people manage cravings – and not just for food and alcohol.
Some preliminary research has suggested the drugs may dampen cravings for smoking, opioid use, gambling, and excessive shopping by hampering activation of the brain’s reward pathways. GLP-1s mimic hormones produced in the gut to suppress a person’s appetite and regulate their blood sugar.
But larger and longer studies will need to confirm the effect of those drugs on addictive behaviors.
Let’s dive into the data.
Researchers recruited people ages 21 to 65 who reported symptoms of alcohol-use disorder but weren’t actively seeking treatment for it. Patients with diabetes and those who have previously used a GLP-1 or other weight loss medications were excluded from the study.
The patients spent two hours in a lab room stocked with their preferred alcoholic beverages – once before they started taking any drugs in the study, and once after to see what had changed. Around half of the people took low doses of semaglutide, the active ingredient in Ozempic, and half received placebo shots weekly for nine weeks.
They also reported their drinking habits and desire for alcohol throughout the study.
Results suggested that Ozempic injections decreased weekly alcohol cravings, cut the average number of beverages consumed on drinking days and led to greater reductions in heavy drinking days when compared to the placebo. Notably, Ozempic’s effect on curbing several drinking outcomes appeared to be greater than what is often seen with existing medications that aim to reduce alcohol cravings.
By the second month of the study, people who took Ozempic were drinking 30% less on average on days they consumed alcohol. That compared to an average reduction of about 2% in the placebo group.
Nearly 40% of people who took Ozempic reported no heavy drinking days in the second month of treatment, compared with 20% in the placebo group.
The study authors noted that they used the two lowest clinical doses of semaglutide in the trial. Higher doses of the drug would “presumably yield greater effects on alcohol reduction,” they added.
“These data suggest the potential of semaglutide and similar drugs to fill an unmet need for the treatment of alcohol use disorder,” senior author Klara Klein of the University of North Carolina School of Medicine, said in a statement. “Larger and longer studies in broader populations are needed to fully understand the safety and efficacy in people with alcohol use disorder, but these initial findings are promising.”
Among a small subgroup of people who smoked, those who took Ozempic had significantly greater reductions in average cigarettes per day compared to those in the placebo group. That suggests Ozempic may reduce both alcohol and nicotine use.
Eli Lilly plans to study whether its weight loss drugs can help treat addictive behaviors like alcohol and drug abuse. The company has said it will start large-scale clinical trials in 2025.
Latest in health-care tech: Primary care doctors are concerned about patients accessing GLP-1s through third-party telehealth providers, survey says
A box of Ozempic and contents sit on a table in Dudley, North Tyneside, Britain, October 31, 2023.
George Frey | Reuters
As demand for blockbuster GLP-1 weight loss drugs has skyrocketed in recent years, some patients have turned to digital health companies like Hims & Hers Health, Ro, Sesame and Noom to access the medications. Primary care physicians don’t think it’s such a good idea.
Metabolic health startup Omada released a survey of more than 2,000 primary care physicians last week that assessed their attitudes toward GLP-1s and various treatment plans. By and large, the doctors said they are concerned about third-party telehealth providers.
Less than 20% of physicians surveyed said they would be comfortable with patients using third-party telehealth providers to access GLP-1 medications. Two-thirds of respondents said they agree that accessing the prescriptions through a third-party telehealth provider could put patients’ health at risk.
“That was alarming, I didn’t even think it would be that high,” Omada President Wei-Li Shao told CNBC in an interview.
Omada does not prescribe GLP-1s, but the company offers a companion program that supports patients who are taking the medications. It also aims to help patients maintain their weight loss if they decide to stop taking the drugs.
The company found that primary physicians are mainly worried about third-party telehealth providers for two reasons: overprescribing and continuity of care. In other words, they’re concerned patients could access GLP-1s when it is not clinically appropriate, and that they might not receive the support they need through additional touch points like follow-up visits.
Additionally, many of the doctors surveyed are on the fence about the role of compounded GLP-1s, which are custom-made alternatives to brand-name drugs designed to meet a specific patient’s needs. Compounded medications can also be produced when brand-name treatments are in shortage.
The FDA doesn’t review the safety and efficacy of compounded products, but they can serve as alternatives to branded medications for patients who are navigating complex supply hurdles and spotty insurance coverage.
Around 45% of physicians surveyed said compounded GLP-1s are not going to be a long-term supply strategy, though they agreed that they can be helpful for addressing current shortages. And 30% of respondents said they agreed or strongly agreed that they are comfortable prescribing compounded GLP-1s.
“Patients or people that are searching for solutions are confused,” Shao said. “What our position has been is talk to your doctor, talk to your primary care doctor, who knows you, knows your history, knows what you’ve been on, and knows what your goals are, and has a perspective on what is the right treatment in partnership with you.”
Feel free to send any tips, suggestions, story ideas and data to Ashley at ashley.capoot@nbcuni.com.
Health plans grapple with costs of new sickle cell gene therapies
It has been just over a year since the FDA approved sickle cell gene therapies. But in some ways the breakthrough drugs are still waiting to launch to treat patients at scale.
With more than half of sickle cell patients covered by Medicaid, expanding coverage for sickle cell therapies could be difficult. States are already facing high medical costs in the joint program with the federal government, and are bracing for potential funding cuts in Congress. Private insurers are facing higher medical costs, too.
CVS Health CEO David Joyner told me private and government health plans alike are looking at new ways to manage the costs of breakthrough gene therapies.
Feel free to send any tips, suggestions, story ideas and data to Bertha at bertha.coombs@nbcuni.com.
Hims & Hers is facing scrutiny from lawmakers over an advertisement for its weight loss offerings that’s slated to run during the Super Bowl on Sunday.
Sens. Dick Durbin, D-Ill., and Roger Marshall, R-Kan., wrote a letter to the U.S. Food and Drug Administration on Friday expressing concerns over an “upcoming advertisement” that “risks misleading patients by omitting any safety or side effect information when promoting a specific type of weight loss medication.”
The Hims & Hers ad, which the company released online in late January, is called “Sick of the System” and sharply criticizes the $160 billion weight loss industry. It shows visuals of existing weight loss medications known as GLP-1s, including injection pens that look like Novo Nordisk’s blockbuster diabetes drug Ozempic.
The ad claims those drugs are “priced for profits, not patients” and points to Hims & Hers’ weight loss medications as “affordable” and “doctor-trusted” alternatives.
“We are complying with existing law and are happy to continue working with Congress and the new Administration to fix the broken health system and ensure that patients have choices for quality, safe, and affordable healthcare,” a Hims & Hers spokesperson told CNBC in a statement.
The senators do not mention Hims & Hers by name in their letter, but they do reference some of the visuals in the ad, including “imagery of an injection pen with distinctive characteristics reflective of an existing brand-name medication.”
“Nowhere in this promotion is there any side effect disclosure, risk, or safety information as would be typically required in a pharmaceutical advertisement,” the senators wrote. “Further, for only three seconds during the minute-long commercial does the screen flash in small, barely legible font, that these products are not FDA-approved.”
Scott Brunner, CEO of the Alliance for Pharmacy Compounding, said Friday that Hims & Hers’ ad is consistent with “help-seeking” pharmaceutical advertising.
“Hims’ Super Bowl ad does not promote a specific drug or medication and therefore is not required to provide information about side effects or risks,” Brunner said in a statement. “Instead, it encouraged viewers to consult with a healthcare provider, which aligns with the FTC’s guidelines for non-specific, ‘help-seeking’ advertisements.”
Hims & Hers began offering compounded semaglutide through its platform in May after launching a new weight loss program in late 2023. Semaglutide is the active ingredient in Ozempic and Wegovy, which can each cost around $1,000 a month without insurance.
Shares of Hims & Hers jumped more than 170% last year, thanks to soaring demand for GLP-1s. They closed up 5% on Friday, lifting the company’s market cap to about $9.5 billion.
Compounded GLP-1s are typically much cheaper and can serve as an alternative for patients who are navigating complex supply hurdles and spotty insurance coverage. Hims & Hers sells compounded semaglutide for under $200 a month.
The FDA doesn’t review the safety and efficacy of compounded products, which are custom-made alternatives to brand-name drugs designed to meet a specific patient’s needs. Compounded products can also be produced when brand-name treatments are in shortage.
Semaglutide is currently in shortage, according to the FDA.
Durbin and Marshall said advertisements for brand-name GLP-1 medications include “significant risk disclosures to patients about side effects and contraindications, including warnings about potential gallbladder, pancreas, vomiting, diarrhea, and other implications.”
A release on Durbin’s website says that the ad in question appears to exploit a loophole “regarding promotions of compounded drugs by telehealth companies.”
The senators said they believe the FDA may have the authority to take enforcement actions against marketing that could mislead patients, and they plan to introduce new legislation to address regulatory loopholes.
