The U.S. FDA has granted accelerated approval to Madrigal Pharmaceuticals' resmetirom, branded Rezdiffra, marking the first treatment to get the nod for non-alcoholic steatohepatitis (NASH).
Rezdiffra, a once-daily, oral THR-β agonist, was approved in conjunction with diet and exercise for the treatment of adults with noncirrhotic NASH with moderate to advanced liver fibrosis. An advanced form of nonalcoholic fatty liver disease, NASH is a leading cause of liver-related mortality, affecting approximately 1.5 million people in the U.S.
The accelerated approval of Rezdiffra was based on results from the phase 3 MAESTRO-NASH trial. Results from the trial, shared in February, demonstrated that both doses of once-daily resmetirom were superior to the placebo in achieving NASH resolution and improving liver fibrosis.
According to Madrigal, the MAESTRO-NASH trial remains ongoing as an outcomes study designed to generate confirmatory data intended to support full approval of Rezdiffra.
