FDA grants fast track designation to Merck’s efinopegdutide for treatment of NASH
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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. Patients were either assigned to subcutaneous efinopegdutide 20 mg/mL once a week or subcutaneous semaglutide once a week for 24 weeks. The primary efficacy outcome is liver fat reduction.
The company noted that data from the trial will be presented during the upcoming EASL Congress on June 23.
“We are looking forward to sharing detailed findings from the phase 2a study of efinopegdutide with the scientific community at the EASL Congress,” Sam Engel, associate vice president of global clinical development at Merck Research Laboratories, said in the press release. “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.”
According to the release, Merck will be initiating a phase 2b randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of efinopegdutide in 300 adults with pre-cirrhotic NASH.
FDA fast track designation is intended to expedite the development and review of drugs that fulfill an unmet need in serious diseases. Benefits of the designation include the potential for more frequent meetings with the FDA during clinical development, eligibility for accelerated approval or priority review, and the ability to submit sections of a biologics license application on a rolling basis.
Perspective
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Jamile’ Wakim-Fleming, MD, FACG, FAASLD
With the rising prevalence of metabolic-associated steatotic liver disease or MASLD, which is the new nomenclature replacing NAFLD, and lack of FDA-approved medications to treat it, a need for efficient therapies has become urgent.
Weight loss, an important armamentarium in the management of MASLD, is hard to achieve and maintain simply by changing lifestyle. Therefore, multiple agents — notably the GLP1RA or drugs in combination with GLP1RA — have been studied and are approved for weight loss and type 2 diabetes but not yet for MASLD. When these agents were studied in MASLD, they were efficient in treating some degree of steatosis and fibrosis. They have reached phase 2b clinical trials with some currently ongoing phase 3 trials.
This FDA fast-track designation for efinopegdutide was based on results from a phase 2b, randomized, double-blind, placebo-controlled, multicenter trial. This drug is a combination GLP1RA with a glucagon receptor co-agonist.
The results were encouraging in the phase 2a trial, in which efinopegdutide was subcutaneously administered and studied in 145 individuals with NAFLD at the dose of 20 mg weekly for 24 weeks compared with another FDA-approved GLP1RA for weight loss and type 2 diabetes. In this phase 2a trial, liver fat content dropped from 20% to less than 5% compared with an 18% drop in the GLP1RA agent.
These results are clearly encouraging. We will have to wait to see if this drug and others make it to the final stage of FDA approval.
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