STAT+: Pharmalittle: We’re reading about Lilly ‘black market’ lawsuits, pushback over Trump vaccine plan, and more
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- Vykat XR safety signal: Physicians and experts in Prader-Willi syndrome notified clinicians of patient deaths and severe side effects potentially associated with Vykat XR, a drug sold by Neurocrine Biosciences that the FDA approved last year to treat the rare disease causing an insatiable desire to eat.
- Death and adverse-event counts: Seven people prescribed Vykat XR have died according to the FDA's Adverse Event Monitoring System, with more than 100 reports of serious adverse events — mostly hospitalizations for swelling, respiratory, and heart complications — filed with the agency.
- Lilly's retatrutide lawsuits: Eli Lilly filed six lawsuits against U.S. businesses — including compounding pharmacies, medical spas, and online sellers — it accuses of illegally selling black-market versions of its experimental obesity drug retatrutide, escalating its campaign before the medicine has won regulatory approval.
- Retatrutide's clinical stage: Retatrutide remains in Phase 3 clinical trials for obesity, type 2 diabetes, and other related conditions, meaning the products accused of being sold are tied to a drug still under clinical development.
- Scope of Lilly's targets: The lawsuits target a range of business types allegedly marketing retatrutide products to consumers despite the drug not yet being approved, according to the drugmaker.
Why it matters: Vykat XR's seven reported deaths and 100-plus serious adverse events — filed via the FDA's monitoring system within roughly a year of approval — raise early real-world safety questions for a drug treating a rare, vulnerable population, while Lilly's pre-approval enforcement actions show drugmakers now treat unauthorized gray-market sales of Phase 3 candidates as worth federal-court time.
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