STAT+: Pharmalittle: We’re reading about Lilly ‘black market’ lawsuits, pushback over Trump vaccine plan, and more — SkimNews
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- Vykat XR drew warnings from Prader-Willi syndrome experts who notified clinicians of patient deaths and severe side effects potentially linked to the Neurocrine Biosciences drug, approved by the FDA last year
- The FDA's Adverse Event Monitoring System has logged seven deaths and over 100 serious adverse events — mostly hospitalizations for swelling, respiratory, and heart complications — among Vykat XR patients since approval
- Eli Lilly filed six lawsuits against U.S. companies it accuses of illegally selling black-market versions of retatrutide, its experimental obesity drug still in Phase 3 clinical trials
- Compounding pharmacies, medical spas, and online sellers are among the defendants Lilly says marketed retatrutide products to consumers despite the drug remaining under clinical development
- Retatrutide is being tested for obesity, type 2 diabetes, and related conditions — meaning the black-market sales occurred well ahead of any FDA approval decision
Why it matters: For the small Prader-Willi patient population with few treatment options, seven deaths and over 100 hospitalizations linked to a year-old drug raise urgent post-market surveillance questions. Lilly's pre-approval lawsuits signal it will defend retatrutide against compounders and online sellers before Phase 3 trials even conclude — an unusual legal posture for a drug not yet on the market.
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