Madrigal Rolling NDA for Resmetirom

Madrigal Pharmaceuticals has begun a rolling NDA submission seeking accelerated approval of resmetirom for treating nonalcoholic steatohepatitis with liver fibrosis. Madrigal says it has submitted the majority of the NDA and plans to submit the rest by 7/30.

“In the MAESTRO-NASH biopsy trial, resmetirom achieved both liver histological improvement endpoints proposed by FDA as reasonably likely to predict clinical benefit and demonstrated a well-tolerated safety profile,” the company says. Enrolled patients (about 1,750) will continue on therapy for up to 54 months to measure hepatic clinical outcome events, including progression to cirrhosis on biopsy and hepatic decompensation events, as well as all-cause mortality, it says. “This portion of the study is designed to generate confirmatory data that, if positive, may help verify resmetirom’s clinical benefit and support full approval,” Madrigal says.