By Josh Nathan-Kazis
The Food and Drug Administration told a federal judge Thursday that it needs more time to reconsider whether Eli Lilly's blockbuster GLP-1 drugs Zepbound and Mounjaro are in shortage.
It's yet another reprieve for the flood of companies selling legal copycat versions of the new weight-loss medicines.
Shares of the telemedicine company Hims & Hers -- which markets a compounded version of a similar medicine sold by Novo Nordisk -- jumped as soon as the filing appeared on the court website, and ended the day up 11%.
The continued delay from the FDA creates even more uncertainty in the market for GLP-1 obesity drugs, which has been flooded with legal, low-price knockoffs of Lilly's Zepbound and Novo's Wegovy.
Novo and Lilly shares have been wobbling in recent weeks after years of dramatic outperformance, amid new worries that investors may have been too optimistic about the demand for the new medicines.
Lilly didn't immediately respond to a request for comment.
Part of the fear is tied to the uncertain future for the compounded versions, which Novo and Lilly say are unsafe. The two companies have asked the FDA to bar the compounders from making them.
The number of Americans currently relying on compounded GLP-1 drugs is unknown, but could be in the hundreds of thousands. Federal law allows compounding pharmacies to make and sell copies of branded drugs when the FDA says that those drugs are in shortage, but the compounders need to stop when the shortages end.
The problem for the FDA today is how to determine that a shortage is over, and what to do about the patients relying on the compounded versions if they disappear.
Today, Novo's semaglutide, sold as both Wegovy and Ozempic, remains on the FDA shortage list. In early October, however, the agency removed Lilly's tirzepatide -- which sells under the brand names Zepbound and Mounjaro -- from the list.
Shortly after tirzepatide came off the list, a compounding industry organization filed a lawsuit to challenge the decision. Faced with the lawsuit, the FDA quickly told the court it would reconsider, and said that even though it had taken tirzepatide off the shortage list, it wouldn't stop compounders from making their versions of the drug for now.
The FDA and the compounding industry group had told the court they would file a joint report on their progress on reconsidering whether tirzepatide was in shortage by Thursday. When that report came on Thursday afternoon, the update was that there is no update.
"FDA has made substantial progress re-evaluating the challenged decision, " the agency said in the court filing. "FDA is carefully assessing the challenged decision and continues to prioritize issuing a new decision."
The industry group that brought the case, the Outsourcing Facilities Association, said it was monitoring tirzepatide supply.
"Production of compounded Tirzepatide products by members of Plaintiff Outsourcing Facilities Association has remained steady or grown, reflecting still more market demand and medical need that is unable to be met by branded Tirzepatide products," the group said in the filing.
The FDA and the Outsourcing Facilities Association said they would file another updated report in mid-December.
The delay appeared to be good news for the compounders, which seem to have been handed yet another month to keep making compounded tirzepatide.
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.
(END) Dow Jones Newswires
November 21, 2024 16:56 ET (21:56 GMT)
Copyright (c) 2024 Dow Jones & Company, Inc.
Comments