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Merck granted Fast Track Designation by the U.S. FDA for MK-6024
for the treatment of Nonalcoholic Steatohepatitis (NASH)
Merck MRK, known as MSD outside of the United States and Canada, announced that new findings for efinopegdutide (MK-6024), an investigational GLP-1/glucagon receptor co-agonist, have been accepted for oral presentation at the European Association for the Study of the Liver (EASL) Annual Congress from June 21-24. Data to be shared include results from the Phase 2a clinical trial evaluating efinopegdutide in adult patients with nonalcoholic fatty liver disease (NAFLD).
Separately, efinopegdutide was recently granted Fast Track Designation from the U.S. Food and Drug Administration (FDA) as a potential treatment for patients with nonalcoholic steatohepatitis (NASH), a more severe form of NAFLD that includes inflammation and damage to the liver. Fast Track is a process designed to facilitate the development and expedite the review of drug candidates to treat serious conditions and fulfill an unmet medical need. Currently, there are no approved therapies for NASH.
“We are looking forward to sharing detailed findings from the Phase 2a study of efinopegdutide with the scientific community at the EASL Congress,” said Sam Engel, associate vice president, global clinical development, Merck Research Laboratories. “Significant patient need remains for new treatment options for NASH. These compelling data in patients with NAFLD, along with the recent receipt of Fast Track Designation from the FDA, provide strong rationale for advancing efinopegdutide into Phase 2b development for patients with NASH.”
Details on Featured Oral Presentation for efinopegdutide
- A Phase 2a, randomized, active-comparator-controlled, open-label study to evaluate the efficacy and safety of efinopegdutide in individuals with nonalcoholic fatty liver disease; Friday, June 23; 8:30-8:45 a.m. CEST.
About MK-6024 (efinopegdutide)
MK-6024 is an investigational peptide and…
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