FDA Grants Accelerated Approval for Rezdiffra for the Treatment of Patients with Noncirrhotic Nonalcoholic Steatohepatitis (NASH)
Madrigal Pharmaceuticals, Inc., announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Rezdiffra (resmetirom) in conjunction with diet and exercise for the treatment of adults with noncirrhotic nonalcoholic steatohepatitis (NASH), with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). Continued approval for this indication may be contingent upon verification and description of clinical benefits in ongoing confirmatory trials.
Rezdiffra is a once-daily, oral THR-beta agonist designed to target key underlying causes of NASH. The accelerated approval of Rezdiffra was based on results from the Phase 3 MAESTRO-NASH trial, which was recently published in the New England Journal of Medicine.
The Rezdiffra prescribing information does not include a liver biopsy requirement for diagnosis. Rezdiffra should not be used in patients with decompensated cirrhosis.
