Novo's Wegovy and Ozempic removed from US FDA shortage list, compounders on notice

By Patrick Wingrove and Bhanvi Satija

(Reuters) - The U.S. Food and Drug Administration said on Friday there was no longer a shortage of Novo Nordisk's popular weight-loss and diabetes drugs, Wegovy and Ozempic, a declaration that will curtail widespread sales of cheaper copies made by compounding pharmacies.

Shares of Hims & Hers Health, which advertised its compounded versions of weight-loss drugs during the Super Bowl this month, plunged 22% to $52, on a day it announced the purchase of a plant to make the class of drugs that includes Wegovy and Ozempic.

U.S. regulations allow compounding pharmacies to copy brand-name medicines that are in short supply. Wegovy and Ozempic, both known chemically as semaglutide, were in shortage in the U.S. for much of last year.

Americans who cannot afford Wegovy or have struggled to find it have been turning to often cheaper versions sold by pharmacies and telehealth providers like Hims & Hers and WeightWatchers. Wegovy has been shown to help patients lose as much as 15% of their weight on average.

WeightWatchers shares were up 5.2% at 77 cents.

For Hims and other compounders, this development starts the clock on having unfettered market access to Novo's drugs, Leerink Partners analyst Michael Cherny said in a note.

The sale of compounded versions of Eli Lilly's rival obesity and diabetes drugs, Zepbound and Mounjaro, was banned in December after the FDA found them to no longer be in short supply. The FDA said in a statement that compounding pharmacies would be given a grace period of 60 to 90 days, as was the case when Lilly's drugs were declared out of shortage.

Robert Califf, who was FDA commissioner under President Joe Biden, said he did not think the agency's declaration would necessarily end obesity drug compounding.

"There so much money to be made. There's just an endless number of tricks that compounders could use," he said in an interview. "So I don't think it's the end of it, but it certainly will bring us into a new era after the time period has passed and all the lawsuits are finished."

Scott Brunner, CEO of the Alliance for Pharmacy Compounding, which represents compounding pharmacists and technicians, questioned whether the FDA took into account the number of patients who will need to transition from compounded drugs to FDA-approved versions before making its announcement.

The Alliance wrote to the FDA last year, saying more than 200,000 prescriptions for semaglutide drugs not manufactured by Novo Nordisk were being filled by U.S. patients each month, and the agency should consider their role in alleviating the obesity drug supply crunch before barring them.

Hims CEO Andrew Dudum said in a posting on X that the company was closely monitoring for potential future shortages of the drugs.

Novo said in a statement that the FDA's assessment confirmed that the U.S. supply of its drugs now meets or exceeds current and projected demand.

U.S. listed shares of the Danish drugmaker rose 6.2% to $88.93.

Novo and Lilly have invested billions to ramp up supply of their treatments, which lagged demand for most of last year.

All doses of Ozempic and Wegovy were listed as available on the FDA's website in October, but the treatments had not been taken off the official shortage list at the time.

The agency usually assesses if all back orders have been filled before deciding on whether a shortage has been resolved.

(Reporting by Bhanvi Satija and Puyaan Singh in Bengaluru, and Patrick Wingrove in New York; Additional reporting by Julie Steenhuysen in Chicago; Editing by Arun Koyyur and Bill Berkrot)