FDA grants fast track designation to Merck’s efinopegdutide for treatment of NASH

The FDA granted fast track designation to efinopegdutide for the treatment of nonalcoholic steatohepatitis, according to a manufacturer’s press release.Efinopegdutide (MK-6024, Merk), an investigational peptide and dual agonist at glucagon-like peptide 1 (GLP-1) and glucagon receptors, is being developed under a licensing agreement between Merck and Hanmi Pharmaceutical.The FDA based its decision on data from a phase 2a, randomized, active-comparator-controlled, open-label study assessing the efficacy and safety of efinopegdutide among 145 patients with nonalcoholic fatty liver disease.Read More