| The FDA issued a warning yesterday for weight-loss drug compounders: the party may soon be over. Why it matters: Sellers profiting from a surge of copycat alternatives to the newly popular GLP-1 drugs are suddenly facing the prospect of being locked out of a red-hot market. Catch up quick The FDA yesterday took tirzepatide injections (Eli Lilly's Mounjaro and Zepbound) off of its official drug-shortage list. - The drugs' appearance on the list 22 months ago had triggered a rush of companies seeking to exploit a loophole that allowed them to sell compounded versions of the injections.
That's all changing. "Pharmacies must immediately cease preparing and dispensing compounded copies of Mounjaro and Zepbound," the Alliance for Pharmacy Compounding said in a statement. - Lilly said those mass-producing compounded and counterfeit tirzepatide "need to stop immediately."
- The message was clear: "Compounders beware," Leerink Partners analyst David Risinger wrote today.
The impact: Telehealth platform Hims & Hers, one of the most prominent companies to offer compounded GLP-1 drugs, saw its stock close down 9.6% today. - Hims doesn't actually offer compounded tirzepatide. It offers a compounded version of semaglutide, the key ingredient in Novo Nordisk's Wegovy, which remains on the FDA's shortage list for now.
Zoom out: Compounders say they're improving access for people who have been prescribed GLP-1s for diabetes and obesity but are still scrambling to find the drugs, Axios' Tina Reed reported in September. - Patients will be "caught flat-footed" by the latest FDA decision, Alliance for Pharmacy Compounding CEO Scott Brunner said in a statement.
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