FDA approves first treatment for liver fibrosis due to NASH

Resmetirom (Rezdiffra) is indicated, along with diet and exercise, for the treatment of adults with noncirrhotic non-alcoholic steatohepatitis (NASH)—also known as metabolic dysfunction-associated steatohepatitis (MASH)—with moderate to advanced fibrosis. Safety and efficacy was evaluated based on an analysis of a surrogate endpoint (extent of liver inflammation/scarring) at month 12 in the ongoing MAESTRO-NASH trial. As a condition of the accelerated approval, the manufacturer will be required to conduct a postapproval study to verify the drug's clinical benefit.