The U.S. Food and Drug Administration (FDA) recently granted accelerated approval for Rezdiffra, a drug for the treatment of adults with noncirrhotic, nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). Conshohocken-based Madrigal Pharmaceuticals, a biopharmaceutical company pursuing therapeutics for NASH, developed the drug.
Accelerated approval was based on the results of a Phase 3 MAESTRO-NASH trial which were published in the New England Journal of Medicine. The ongoing randomized, double-blind, placebo-controlled trial enrolled 1,759 patients with biopsy-confirmed NASH. After 52 weeks, both 100 milligram and 80 milligram doses demonstrated statistically significant improvement compared to placebo.
“NASH with moderate to advanced liver fibrosis is a serious and progressive liver disease that, until now, has not had an FDA-approved therapy,” Bill Sibold, Madrigal CEO, said. “The accelerated approval of Rezdiffra is a culmination of more than 15 years of research from our founder Dr. Becky Taub and a small (research and development) team that took on one of the biggest challenges in drug development. This is a historic moment for the NASH field and represents the best of what our industry is capable of. We’re excited to deliver Rezdiffra to patients in need.”
Continued approval may be contingent upon ongoing confirmatory trials.