Wegovy Receives FDA MASH Approval as the First GLP-1RA

Wegovy Approval: Novo Nordisk's weight loss drug Wegovy (semaglutide) has received FDA approval for treating metabolic dysfunction-associated steatohepatitis (MASH) with moderate-to-advanced liver scarring, making it the first GLP-1RA approved for this condition.

Clinical Trial Results: The approval was based on the Phase III ESSENCE trial, which showed that Wegovy resolved steatohepatitis in 63% of patients and improved liver fibrosis in 37%, compared to lower rates in the placebo group.

Market Competition: Wegovy now competes with Madrigal Pharmaceuticals' Rezdiffra, which is also approved for MASH. Analysts predict Rezdiffra could achieve blockbuster status by 2026, highlighting a competitive landscape between the two drugs.

Ongoing Developments: While Wegovy has gained early approval, Lilly is also pursuing label expansion for its drug Zepbound in the same indication, indicating ongoing competition in the GLP-1RA market.