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Economy And The Numbers

Madrigal Pharma: CHMP Adopts Positive Opinion Recommending Approval Of Resmetirom

By RTTNews Staff Writer   ✉  | Published:  | Google News Follow Us  | Join Us
rttnewslogo20mar2024

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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