Korea-US NASH Treatment 'Epinofegduptide' Designated for FDA Fast Track

Hanmi Pharmaceutical's non-alcoholic steatohepatitis (NASH) treatment candidate 'Epinofpegdutide,' licensed to the U.S. company Merck (MSD), has been designated as a Fast Track product by the U.S. Food and Drug Administration (FDA).

Exterior view of Hanmi Pharm headquarters building
[Photo by Hanmi Pharm]

On the 12th (local time), MSD announced that the FDA recently designated Epinofpegdutide as a Fast Track product for the treatment of NASH. The Fast Track designation is a procedure implemented by the FDA to accelerate the development and review process of candidate drugs in important areas such as treatments for serious diseases, aiming to provide new drugs to patients earlier.

Epinofpegdutide is a dual agonist that simultaneously activates the glucagon-like peptide (GLP)-1 receptor, which helps insulin secretion and appetite suppression, and the glucagon receptor, which increases energy metabolism. It was licensed to MSD in August 2020.

MSD also announced that it will present oral results of a Phase 2a clinical trial evaluating Epinofpegdutide in adult patients with non-alcoholic fatty liver disease (NAFLD) at the European Association for the Study of the Liver (EASL) conference, held from the 21st to 24th in Vienna, Austria.

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