The U.S. Food and Drug Administration granted accelerated approval to Novo Nordisk’s once-weekly Wegovy (semaglutide 2.4 mg) for treating adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) who have moderate to advanced liver fibrosis. The decision broadens the blockbuster therapy’s use beyond weight management and cardiovascular risk reduction. Wegovy becomes the first glucagon-like peptide-1 receptor agonist cleared for MASH and only the second FDA-approved therapy for the disease after Madrigal Pharmaceuticals’ Rezdiffra, authorised in 2024. MASH is a progressive form of fatty-liver disease that affects about one in 20 U.S. adults and can lead to cirrhosis, cancer or transplantation. Regulators based the nod on interim results from the Phase 3 ESSENCE study. After 72 weeks, 63 % of patients on Wegovy achieved resolution of MASH with no worsening of fibrosis, compared with 34 % for placebo. Improvement in fibrosis with no worsening of steatohepatitis was seen in 37 % of treated patients versus 22 % on placebo. A second part of the trial, designed to confirm long-term clinical benefit, runs through 2029. Novo Nordisk said it has also sought approvals in Europe and Japan. The company’s U.S.-listed shares rose about 5–6 % in after-hours trading following the announcement.
$NVO OMFG after hrs… I’m on a heater with my picks lol. https://t.co/f2Tqp0cY8P https://t.co/2aK7wnRSjt
Novo Nordisk's Wegovy gets accelerated US approval for liver disease MASH https://t.co/WtZF07t1Hx https://t.co/WtZF07t1Hx
🚨BREAKING: FDA grants accelerated approval to Wegovy (semaglutide 2.4 mg injection) for treating adults with non‑cirrhotic metabolic dysfunction‑associated steatohepatitis (MASH) with moderate to advanced liver fibrosis - - - A Fourth Indication for Wegovy Wegovy’s FDA-approved https://t.co/a01rKqQSIt