FDA Grants Accelerated Approval to Madrigal’s Rezdiffra for MASH Treatment

1. The U.S. Food and Drug Administration (FDA) granted accelerated approval to Madrigal Pharmaceuticals' drug, Rezdiffra (resmetirom), marking the first approval for treating metabolic dysfunction-associated steatohepatitis (MASH).
2. Rezdiffra demonstrated resolving symptoms of MASH and improving liver fibrosis without worsening the condition in Phase 3 clinical trials.
3. Common side effects associated with Rezdiffra include diarrhea, nausea, vomiting, and an increase in sex hormones.
4. The approval comes with the condition that Rezdiffra's benefits must be confirmed in ongoing trials to maintain its accelerated clearance status.
5. Rezdiffra will be used alongside diet and exercise for adult patients with non-cirrhotic MASH and moderate-to-advanced liver fibrosis.
6. The drug has also shown potential broader benefits by lowering markers of heart disease.
7. Despite the approval, Madrigal faces challenges due to debates about sales potential and competition from other drugs targeting weight loss and obesity, such as Eli Lilly’s Zepbound and Boehringer and Zealand Pharma’s survodutide, which have produced favorable early study results.