Overview
- U.S. regulators granted accelerated approval for Wegovy to treat metabolic dysfunction‑associated steatohepatitis in adults with moderate to advanced fibrosis, the first GLP‑1 cleared for this liver disease.
- The decision rests on the first phase of the ESSENCE trial, where Wegovy showed higher rates of steatohepatitis resolution versus placebo (62.9% vs 34.3%) and fibrosis improvement, with confirmatory data still expected.
- Novo Nordisk introduced a $499 per month cash price for Ozempic through its NovoCare pharmacy and a GoodRx partnership, matching its existing Wegovy cash offer for eligible self‑pay patients.
- Shares of Novo Nordisk rose by mid‑single digits intraday after the announcements, while GoodRx jumped roughly 30%–39% on expectations of increased traffic and sales.
- Novo has sought MASH approvals in Europe and Japan and faces pressure from Eli Lilly’s tirzepatide programs and the continued presence of compounded semaglutide products in the U.S. market.