Hanmi Pharm's Efinopegdutide gets Fast Track Designation from FDA

Merck, known as MSD outside the United States and Canada, announced on Monday that Efinopegdutide, a technology transferred from the South Korean pharmaceutical company Hanmi Pharmaceutical Co., was granted Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the treatment of nonalcoholic steatohepatitis (NASH).

The fast-track designation is a process by which the FDA accelerates the review speed to provide early access to patients for important new drugs in critical areas, such as the treatment of severe diseases. Currently, there are no approved treatments for NASH.

Efinopegdutide is a dual-action agent that activates both the GLP-1 receptor, which helps with insulin secretion and appetite suppression, and the glucagon receptor, which increases energy metabolism. Hanmi Pharm transferred the technology for efinopegdutide to MSD in Aug. 2020.

MSD plans to orally present the results of phase 2a clinical trial of efinopegdutide, conducted on adult patients with nonalcoholic fatty liver disease, at the European Association for the Study of the Liver (EASL) in Vienna, Austria, from June 21 to 24.

"The phase 2a results of efinopegdutide, which will be unveiled at EASL, along with the FDA's fast-track designation, will expedite the commercialization of efinopegdutide," an Hanmi Pharm official said. 

Write to Yoo-Rim Kim at youforest@hankyung.com