Dj Madrigal Pharmaceuticals Gets Chmp Backing For Rezdiffra Approval

By Colin Kellaher

Madrigal Pharmaceuticals said the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of its Rezdiffra treatment for adults with the liver disease noncirrhotic MASH who have moderate to advanced fibrosis.

Madrigal on Friday said a green light would make Rezdiffra the first medication approved in the E.U. for MASH, which is the fastest-growing indication for liver transplantation in Europe.

The West Conshohocken, Pa., biopharmaceutical company said it expects a final decision from the European Commission, which generally follows the CHMP's advice, in the August.

The U.S. Food and Drug Administration in March 2024 granted accelerated approval to Rezdiffra, which generated sales of more than $137 million in the first quarter of 2025.

Write to Colin Kellaher at colin.kellaher@wsj.com

Madrigal Pharmaceuticals said Friday it received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use for resmetirom to treat noncirrhotic metabolic dysfunction-associated steatohepatitis with moderate to advanced liver fibrosis.

The recommendation followed positive results from the phase 3 Maestro-Nash trial, showing both fibrosis reduction and MASH resolution, the company said.

If approved by the European Commission in August, resmetirom will be the first treatment for MASH in the EU, Madrigal said.

The drug has also been approved by the Food and Drug Administration for MASH in the US, under certain conditions, the company added.

Madrigal shares rose by more than 1.5% in recent Friday premarket activity.