Madrigal Pharma: CHMP Adopts Positive Opinion Recommending Approval Of Resmetirom

(RTTNews) - Madrigal Pharmaceuticals, Inc. (MDGL) announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending approval of resmetirom, or Rezdiffra, for the treatment of adults with noncirrhotic MASH with moderate to advanced liver fibrosis. The European Commission decision is anticipated in August. The U.S. Food and Drug Administration granted accelerated approval in March 2024 for Rezdiffra in conjunction with diet and exercise for the treatment of adults with noncirrhotic MASH with moderate to advanced liver fibrosis.

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