By Josh Nathan-Kazis

Novo Nordisk took its most aggressive swipe yet at the compounding pharmacies hawking legal copycats of its weight-loss blockbuster Wegovy, asking the Food and Drug Administration to entirely bar compounders from making the medicine.

The Danish drugmaker asked the agency to put semaglutide, the active ingredient in Wegovy and Ozempic, on a list of drugs that compounding pharmacies aren't allowed to make.

The underlying rule that bars compounders from making drugs on that list has been stuck in a byzantine FDA regulatory process for years, and hasn't yet gone into effect.

What's more, putting semaglutide on the list would be a lengthy process, with no guarantee of success for Novo.

The company's request, however, shows it is focused on targeting the sprawling weight loss drug industry that has grown up around the compounding pharmacies, which are allowed to legally sell compounded versions of semaglutide as long as Novo's supply capacity cannot meet U.S. demand.

Shares of Hims & Hers Health, a telemedicine provider that sells compounded Wegovy, fell 8.6% Wednesday. Novo shares were down 1.2%.

Novo has spent billions of dollars in recent years increasing its capacity to make GLP-1 medicines like semaglutide, but remains unable to meet the enormous demand for its drugs. While it currently reports limited availability of only one dosage level of Wegovy, the FDA considers the medicine to still be in shortage.

As long as the shortage persists, U.S. compounders are able to make and sell their own, cheaper versions of the medicine, using semaglutide not made by Novo.

Since early this year, a growing number of telehealth providers have rushed into the market, providing U.S. patients with cheap and easy access to compounded semaglutide. Hims & Hers, Noom, Weight Watchers, Ro, and a long list of similar companies offer compounded semaglutide prescriptions for roughly $300 a month, a fraction of the drug's list price. They advertise heavily, particularly on social media.

Many of the companies also offer compounded tirzepatide, the ingredient in Eli Lilly's Zepbound and Mounjaro.

The number of patients currently taking compounded semaglutide or tirzepatide is unknown, but could be in the hundreds of thousands. FDA rules will bar the compounders from making the drugs once the agency has determined they are no longer in shortage, raising the specter of a crisis if patients are suddenly cut off from their drugs.

Uncertainty has shrouded the market in recent weeks, after the FDA removed tirzepatide from its shortage list, but then said it would allow compounders to make the medicine for now after facing a legal challenge.

The new letter from Novo asking the FDA to put semaglutide on its list of drugs excluded from compounding argues that semaglutide is too complex to be compounded. The letter, posted online by the FDA on Monday, says that the semaglutide used by compounders is made differently than the semaglutide used in Wegovy, and that the method used by the compounders' suppliers can leave behind impurities that could induce a negative immune response.

The company also said that distributing the drugs in vials, as compounders do, rather than in auto-injectors, as Novo does, could lead to over-or-under dosing.

The Alliance for Pharmacy Compounding, a trade group representing compounders, hit back at Novo in a statement late Tuesday.

"Let me get this straight: So Novo Nordisk is apparently so deeply concerned about patient safety that it's taken them a whopping two-and-a-half years while their drug has been in shortage to conclude that the semaglutide API is so demonstrably difficult for compounding pharmacies to prepare that FDA now needs to place it off-limits for compounding?," the group's CEO, Scott Brunner, said in the statement. "To me, this looks more like desperation and an attempt by Novo to protect its revenue stream than a serious scientific argument."

In a statement, Novo said that its request to bar the compounding of semaglutide was tied to safety issues. "Our nomination is driven by our focus on patient safety and contains extensive scientific evidence," the company told Barron's. "We urge FDA to swiftly consider the information provided to the Agency and convene a public advisory committee meeting on this critical public health issue."

Write to Josh Nathan-Kazis at josh.nathan-kazis@barrons.com

This content was created by Barron's, which is operated by Dow Jones & Co. Barron's is published independently from Dow Jones Newswires and The Wall Street Journal.

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October 23, 2024 12:00 ET (16:00 GMT)

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