India, March 15 -- Madrigal Pharmaceuticals, Inc. (MDGL) announced that the U.S. Food and Drug Administration (FDA) has approved Rezdiffra (resmetirom) along with diet and exercise for the treatment of adults with noncirrhotic Nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis.
Rezdiffra becomes the first and only medication approved by the FDA for the treatment of NASH, also known as metabolic dysfunction associated steatohepatitis (MASH).
The company specified that the accelerated approval was based on Phase 3 data demonstrating that Rezdiffra improved liver fibrosis and resolved NASH in patients with noncirrhotic NASH with moderate to advanced liver fibrosis.
NASH, also known as metabolic dysfunction-associat...