FDA grants accelerated approval to Rezdiffra (resmetirom), the first drug approved for MASH

Madrigal Pharmaceuticals/Rezdiffra

Madrigal announced FDA accelerated approval of Rezdiffra for MASH, making it the first approved pharmacological treatment for the disease. Approval was based on 52-week Phase 3 MAESTRO-NASH data showing statistically significant improvement in MASH resolution and fibrosis without worsening. A confirmatory outcomes trial is ongoing through 2028.