FDA Grants Fast Track Designation for Efinopegdutide for NASH

The US Food and Drug Administration (FDA) granted Fast Track Designation to efinopegdutide (MK-6024) for the treatment of nonalcoholic steatohepatitis (NASH), Merck announced June 12.

The company said in a news release, “MK-6024 was investigated in a randomized, active comparator-controlled, open-label Phase 2a study to evaluate the compound’s efficacy in liver fat reduction and safety in participants with nonalcoholic fatty liver disease.” Findings from this study will be the subject of an oral presentation at the European Association for the Study of the Liver (EASL) Annual Congress on June 23.

FDA’s Fast Track is designed to facilitate the development and expedite the review of drug candidates to treat serious conditions and fulfill an unmet medical need. There are at present no approved therapies for NASH.

It is estimated that some 25% to 30% of people in the U.S. are living with NAFLD and about 2% to 5% have advanced to NASH.

Reference:
Merck to present data for efinopegdutide (mk-6024), an investigational glp-1/glucagon receptor co-agonist, in patients with nonalcoholic fatty liver disease (NAFLD) at EASL 2023. Press release. Merck. June 12, 2023. Accessed June 19, 2023. https://www.merck.com/news/merck-to-present-data-for-efinopegdutide-mk-6024-an-investigational-glp-1-glucagon-receptor-co-agonist-in-patients-with-nonalcoholic-fatty-liver-disease-nafld-at-easl-2023/