Madrigal closes on EU approval of first MASH treatment

Madrigal Pharma could be just weeks away from becoming the first drugmaker to claim EU approval for a treatment for metabolic dysfunction-associated steatohepatitis (MASH).

The EMA’s human medicines committee, the CHMP, has recommended a conditional marketing authorisation for Madrigal’s oral thyroid hormone receptor (THR) β-selective agonist Rezdiffra (resmetirom) for adults with MASH – also known as non-alcoholic steatohepatitis (NASH) – who have moderate to advanced liver scarring (fibrosis), but who have not developed cirrhosis.

The positive opinion covers wording that is very…