EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Rezdiffra (resmeritom) for the treatment of adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis, in conjunction with diet and exercise.
MASH is a serious disease where fat deposits accumulate in the liver causing inflammation. MASH is often associated with several cardiovascular (of the heart and blood vessels) and metabolic diseases and, if left untreated, it can lead to cirrhosis (severe and permanent scarring of the liver) and cancer. Currently, there is no authorised treatment for MASH in the EU.
The active substance of Rezdiffra is resmetirom, a liver therapy. Resmetirom stimulates a thyroid hormone receptor (THR‑β) in the liver, reducing the accumulation of fat in the liver, inflammation and liver fibrosis (tissue scarring and thickening)…
