Overview

• The U.S. Food and Drug Administration granted accelerated approval for Wegovy to treat adults with metabolic-associated steatohepatitis who have moderate to advanced liver scarring, with use alongside reduced-calorie diet and increased exercise.
• Part one of a two-part Phase III trial showed 37% of patients on Wegovy experienced fibrosis improvement compared with 22% on placebo, and inflammation resolved in nearly twice as many treated participants.
• The FDA’s clearance makes Wegovy the first drug in its GLP-1 class approved for MASH, following Madrigal’s Rezdiffra which was the only available treatment since 2024.
• Novo Nordisk’s American depositary receipts jumped about 6% while shares of Madrigal Pharmaceuticals fell roughly 6.5% in response to the decision.
• Novo has filed for MASH approvals in Europe and Japan and must complete part-two confirmatory trials by 2029 to maintain market authorization, with pricing and reimbursement negotiations to follow.