US FDA approves first drug for fatty liver disease NASH

The U.S. FDA has approved Madrigal Pharmaceuticals' drug for a fatty liver disease known as non-alcoholic steatohepatitis (NASH), the first treatment to get the nod for the condition and opening up a multi-billion opportunity.

The company's oral drug, called Rezdiffra, has been approved for patients who have NASH with fibrosis, or scarring, that has progressed to stage 2 or 3 in severity, according to an FDA label released on Thursday.

NASH, which was recently renamed metabolic dysfunction-associated steatohepatitis (MASH), affects about 1.5 million people in the United States, according to the company's estimates, but there was no approved treatment for it until now.