pharmaphorum March 15, 2024
Madrigal Pharma has become the first drugmaker to claim FDA approval for a drug to treat metabolic dysfunction-associated steatohepatitis (MASH), an elusive target that has seen many other experimental therapies fall by the wayside.
The US regulator has cleared Madrigal’s oral 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.
Importantly for Madrigal, it has not required a liver biopsy before treatment, which analysts have suggested could have been a barrier to take-up.
MASH is a form of non-alcoholic fatty liver disease (NAFLD) that affects between 6 million to 8 million people in the US alone and for...
Today's Sponsors
Today's Sponsor