FDA approves Madrigal’s NASH drug, marking the first-ever treatment for the liver disease

Madrigal Pharmaceuticals’ NASH drug won an accelerated approval on Thursday, becoming the first treatment for a liver disease that for years has vexed scientists and investors.

The medication, resmetirom, was approved under the brand name Rezdiffra for patients with stage 2 and 3 fibrosis. It’s expected to be available in April, according to Madrigal. While the FDA described the disease as NASH in its label, it is now often referred to as metabolic dysfunction-associated steatohepatitis (MASH).

The company declined to comment on the price it will charge for Rezdiffra, its first approved drug. Earlier this year, CEO Bill Sibold touted resmetirom as a specialty drug that “provides tremendous value” in a high-need area and would be priced as such. ICER, a drug pricing watchdog, determined in May that the drug would be cost-effective if it was priced between $39,600 and $50,100 per year.


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