Madrigal starts rolling submission for NASH drug application with US FDA

[July 01, 2023]  (Reuters) - Madrigal Pharmaceuticals said on Friday it has started the application process to secure a speedy approval in the U.S. for its experimental drug to treat a type of fatty liver disease, which currently has no approved medicines.

The company said it started a rolling submission of its data for resmetirom with the U.S. Food and Drug Administration, and plans to complete the application process by July and request a priority review for it.

A rolling review means a regulator assesses the data as it becomes available, and the process continues until there is enough data for a formal marketing application.

Resmetirom has been seen as a promising candidate for the treatment of nonalcoholic steatohepatitis (NASH) since its late-stage study in December helped reduce liver scarring or fibrosis in patients and propelled it to the forefront in the race for the first approved treatment for the disease.

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo

NASH, which can progress to liver failure, affects 5% of the U.S. population, but development of a drug for the disease has seen numerous clinical failures, most recently by Intercept Pharmaceuticals.

Approved treatments for the disease are expected to generate a multibillion dollar market in the United States, with Novo Nordisk as well as other smaller companies racing to develop the drugs.

(Reporting by Raghav Mahobe and Mariam Sunny in Bengaluru; Editing by Shilpi Majumdar)

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