Madrigal Pharmaceuticals, Inc. has announced the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for accelerated approval of its drug resmetirom for the treatment of nonalcoholic steatohepatitis (NASH) with liver fibrosis. The company expects to complete the full submission of the NDA in July 2023.
Resmetirom was granted Breakthrough Therapy designation in April 2023 and Madrigal was allowed to submit individual sections of the NDA as they were completed. The drug achieved positive results in clinical trials, meeting FDA's proposed endpoints for liver histological improvement and demonstrating a well-tolerated safety profile.
Madrigal is committed to addressing the unmet medical need for NASH patients with liver fibrosis and believes that resmetirom has the potential to become a foundational therapy for this condition. The company will work closely with the FDA during the review process.