By Josh Nathan-Kazis
The Food and Drug Administration said Thursday that the longstanding shortage of Eli Lilly's weight-loss drug Zepbound and its Type 2 diabetes medicine Mounjaro is officially over.
The determination comes two months after the FDA first removed the ingredient in both medicines, known as tirzepatide, from its shortage list. The agency faced an immediate legal challenge to its initial decision and agreed to reconsider the determination. The FDA said that its reconsideration is now over and it stands by its initial decision that the drug is no longer in shortage.
Shares of Lilly were down 0.9% after the market opened.
The removal of tirzepatide from the shortage list would generally bar compounding pharmacies from making their own versions of the medicine. Federal law allows compounders to make copycat versions of branded drugs when those drugs are in shortage. An enormous industry has sprung up to sell compounded tirzepatide in recent months.
The FDA said, however, that it will continue to allow certain compounders to keep making compounded tirzepatide until Feb. 18 and other compounders to keep making compounded tirzepatide until March 19.
That has sweeping implications for the telehealth companies selling compounded tirzepatide and compounded semaglutide, the generic name of Novo Nordisk's Wegovy.
Shares of Hims & Hers Health, an online telemedicine company that sells compounded semaglutide, were down 8.6% following the news. Though Hims doesn't sell compounded tirzepatide, it is virtually alone among its peers to be publicly listed and trades as a proxy for the online telehealth industry.
Novo's American depositary receipts were down 2.5%.
Write to Josh Nathan-Kazis at josh.nathan-kazis@barrons.com
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(END) Dow Jones Newswires
December 19, 2024 10:14 ET (15:14 GMT)
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