MDGL - FDA Conditionally Approves Madrigal Pharmaceuticals' Resmetirom As First Treatment For Fatty Liver Disease With Scarring | Benzinga
The FDA granted accelerated approval on Thursday to Madrigal Pharmaceuticals Inc.’s (NASDAQ:MDGL) Rezdiffra (resmetirom) noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver scarring (fibrosis) to be used along with diet and exercise.
Continued approval for this indication may be contingent upon verification and description of clinical benefit in ongoing confirmatory trials.
This marks the first FDA approval of a treatment for patients with liver scarring due to fatty liver disease.
Rezdiffra is a once-daily, oral THR-? 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 that enrolled ...