FDA approves first MASH drug: Madrigal's Rezdiffra breaks ground in notorious biopharma graveyard
Overview
The decades-long wait for an effective treatment for metabolic dysfunction-associated steatohepatitis (MASH) has ended, as the FDA has approved the first drug for the fatty liver disease.
First Therapy
- After a long and winding drug development path for the common disease, Madrigal Pharmaceuticals’ resmetirom, to be sold under the brand name Rezdiffra, has become the first MASH therapy to clear the FDA finish line.
- Thursday, the FDA approved the tablet drug for the treatment of MASH, also known as nonalcoholic steatohepatitis (NASH), with moderate or severe liver scarring, or fibrosis, consistent with stage F2 and F3 disease, according to a product label (PDF) posted on the FDA’s website.
About Rezdiffra
- Rezdiffra emerged successful from a notorious drug development graveyard about four decades after the term NASH was first coined by researchers at Mayo Clinic.
- Its approval sets the bar for many other companies that are also eying the field, which is estimated to affect about 5% of adults in the U.S.
