By Patrick Wingrove and Bhanvi Satija (Reuters) – The U.S. Food and Drug Administration announced on Friday that the shortage of Novo Nordisk’s widely used weight-loss and diabetes medications, Wegovy and Ozempic, has been resolved. This declaration will restrict the availability of cheaper generic versions produced by compounding pharmacies.
In the United States, regulations permit compounding pharmacies to replicate brand-name medications that are in short supply. Semaglutide, the chemical name for Wegovy and Ozempic, had been in short supply in the U.S. for a significant portion of the previous year.
The sale of compounded alternatives to Eli Lilly’s competitive weight-loss and diabetes treatments, Zepbound and Mounjaro, was prohibited in December following the FDA’s determination that they were no longer in short supply.
According to the FDA, compounding pharmacies will be granted a grace period of 60 to 90 days, similar to the one provided when Lilly’s medications were declared to be in adequate supply. Individuals in the U.S. who face financial constraints or have experienced difficulties in obtaining Wegovy have been resorting to more affordable versions offered by pharmacies and telehealth providers such as Hims & Hers Health and WeightWatchers.
Clinical studies have demonstrated that Wegovy can assist patients in achieving an average weight loss of up to 15%. An industry group informed the FDA in a letter last year that over 200,000 prescriptions for semaglutide medications, not produced by Novo Nordisk, were being filled by U.S. patients each month. The group suggested that the FDA should consider the crucial role these medications play in alleviating the shortage of obesity drugs before imposing restrictions on them.
Leerink Partners analyst Michael Cherny stated that for Hims and other compounders, this development marks the beginning of unhindered access to Novo’s drugs in the market. In terms of stock performance, Hims & Hers shares fell by 21% to $52.66, while WeightWatchers’ shares rose by 6.4% to 78 cents during morning trading. Neither company responded immediately to requests for comment. Novo Nordisk and Eli Lilly have made significant investments in expanding the supply of their medications, which had struggled to meet the demand for most of the previous year.
Novo Nordisk mentioned in a statement that all doses of Wegovy and Ozempic are now being regularly shipped to wholesalers, and this resolution follows ongoing discussions with the FDA. In October, all doses of Ozempic and Wegovy were listed as available on the FDA’s website, even though the treatments had not yet been removed from the official shortage list at that time. The FDA typically evaluates whether all back orders have been fulfilled before determining the resolution of a shortage issue.
(Reporting by Bhanvi Satija and Puyaan Singh in Bengaluru;
