Madrigal Pharmaceuticals' Rezdiffra was authorized by the UK's MHRA, making it the first approved oral treatment for metabolic dysfunction-associated steatohepatitis (MASH) in both the U.S. and UK.
Rezdiffra is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. The MHRA authorization covers adult patients who have experienced inflammation and cell damage, resulting in moderate scarring, consistent with stage 2 fibrosis, or significant scarring, consistent with stage 3 fibrosis.
The FDA first cleared Rezdiffra in March 2024 for the treatment of stage F2 and F3 noncirrhotic MASH with moderate to advanced liver fibrosis. The landmark approval was based on the pivotal MAESTRO-NASH phase 3 trial, which showed significant fibrosis improvement versus placebo.