FDA Approves First Treatment for Severe Liver Disease NASH

Madrigal Pharmaceuticals' Rezdiffra receives accelerated approval, marking a significant advancement in liver disease treatment.

The FDA has granted accelerated approval to Madrigal Pharmaceuticals' Rezdiffra, the first drug for treating non-cirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver scarring.
Rezdiffra, also known as resmetirom, is an oral drug that showed significant improvement in liver scarring and NASH resolution in clinical trials.
The drug is expected to be available to U.S. patients in April and will be distributed through a limited specialty pharmacy network.
Madrigal Pharmaceuticals' stock soared following the FDA approval, reflecting the high market anticipation for this groundbreaking treatment.
Continued approval of Rezdiffra will depend on the verification and description of clinical benefits in ongoing confirmatory trials.