Eli Lilly has filed lawsuits against medical spas and online vendors for allegedly selling unauthorized versions of tirzepatide, the active ingredient in its weight-loss medication, Zepbound. This action comes despite the recent resolution of the FDA-declared tirzepatide injection shortage. Eli Lilly argues that these vendors are offering counterfeit products without FDA approval and are engaging in misleading advertising practices.
Hims & Hers Health Inc. (HIMS) shares surged on Monday after the FDA announced a reconsideration of its decision to prohibit drug compounders from selling their own versions of blockbuster weight loss medications. This decision stems from a lawsuit filed by the Outsourcing Facilities Association, challenging the FDA’s removal of tirzepatide, the active ingredient in Eli Lilly’s Mounjaro and Zepbound, from its shortage list.
The FDA has declared the shortage of tirzepatide, a popular weight-loss drug, resolved. However, semaglutide, another weight-loss medication, remains in short supply. This development raises questions about the long-term viability of compounded GLP-1 treatments, with Hims & Hers Health, a provider of compounded GLP-1s, seeing continued strong demand, but facing investor concerns.
The NHS in England is planning a phased rollout of tirzepatide, a promising weight-loss drug, to benefit patients most likely to see significant clinical outcomes. The drug, which has shown impressive results in trials, will be made available through community-based services and digital health platforms, with the goal of reaching 240,000 people over the first three years. The plan is currently under consultation, with final guidance from NICE expected later this year.
