15Mar 2024
FDA Grants Accelerated Approval for Madrigal Pharmaceuticals' Rezdiffra for NASH Treatment

FDA Grants Accelerated Approval for Madrigal Pharmaceuticals' Rezdiffra for NASH Treatment

Madrigal Pharmaceuticals, Inc., announced that the U.S. Food and Drug Administration (FDA) had granted accelerated approval for Rezdiffra (resmethrin) for the treatment of adults with noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis (stages F2 to F3 fibrosis). This marks a significant milestone as the first FDA-approved therapy for this condition. Rezdiffra, a once-daily oral THR-β agonist, targets critical underlying causes of NASH. The approval is based on positive results from the Phase 3 MAESTRO-NASH trial, demonstrating improvement in both NASH resolution and fibrosis compared to placebo. This approval represents a breakthrough in addressing a severe and progressive liver disease with limited prior therapeutic options.

  • #family health

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