STAT+: Pharmalittle: Lilly sues spas and compounders over ‘unapproved’ Mounjaro; nasal-spray EpiPen alternative suffers setback
Eli Lilly sued several compounding pharmacies, spas, and wellness centers for selling unapproved versions of Mounjaro.
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As the gold rush over weight-loss drugs accelerates, Eli Lilly filed lawsuits against several compounding pharmacies, spas and wellness centers around the U.S. for selling unapproved versions of its Mounjaro diabetes drug, which is frequently used for combating obesity, STAT writes. The drug company accused four compound pharmacies of violating state laws because those versions were not approved by the U.S. Food and Drug Administration. In other lawsuits, Lilly accused several medical spas and wellness centers of trademark violations, false advertising, and unfair competition by selling drugs under the Mounjaro name.
The FDA declined to approve an application from ARS Pharmaceuticals for its lead product, which would become the first needle-free epinephrine product to treat severe allergic reactions, Pharmaphorum notes. The nasal spray, dubbed neffy, has been filed for use in adults and some children as an alternative to epinephrine injections such as EpiPen – which dominates the market for emergency medications for anaphylaxis – or its generic equivalents. ARS Pharma said it was “very surprised” by the complete response letter, since an FDA advisory committee recommended approval of the drug in May without any additional trials by a vote of 16 to 6.
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