FDA Accelerated Approval for Madrigal’s Rezdiffra™ in Win for NASH Patients

Shares in Madrigal Pharmaceuticals (Nasdaq: MDGL) soared this week after the FDA granted accelerated approval of the company’s drug candidate Rezdiffra™ in the treatment of nonalcoholic steatohepatitis (NASH). This represents the first and only drug to be approved for NASH, an advanced liver disease and a leading cause of liver-related mortality, that affects between 1.5% and 6.5% of the US adult population.

Rezdiffra is a once-daily, oral THR-β agonist designed to target key underlying causes of NASH.

Becky Taub, M.D., the Founder, Chief Medical Officer and President of Research & Development of Madrigal, stated, “Madrigal would like to thank the many patients who made the accelerated approval of Rezdiffra possible by participating in our clinical studies. We believe Rezdiffra will change the treatment paradigm for NASH with moderate to advanced liver fibrosis, giving physicians a liver-directed therapy to help improve fibrosis and resolve NASH before their patients progress to cirrhosis.”

Highlights

The accelerated approval of Rezdiffra was based on results from Madrigal’s Phase 3 MAESTRO-NASH trial, an ongoing pivotal, multicenter, randomized, double-blind, placebo-controlled study that enrolled 1,759 patients with biopsy-confirmed NASH. Results of the study were recently published in the New England Journal of Medicine.

The trial demonstrated that 100 mg and 80 mg doses of Rezdiffra demonstrated statistically significant improvement compared to placebo on NASH resolution with no worsening of fibrosis.

Fibrosis improvement and NASH resolution were consistent regardless of age, gender, type 2 diabetes status, or fibrosis stage.

Madrigal estimates that approximately 1.5 million patients have been diagnosed with NASH in the U.S., of which approximately 525,000 have NASH with moderate to advanced liver fibrosis.

About Madrigal Pharmaceuticals

Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) is a biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), a liver disease with high unmet medical need. Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of NASH. For more information, visit www.madrigalpharma.com.