Merck’s efinopegdutide shows promise in nonalcoholic fatty liver disease

2023-06-14
临床2期引进/卖出上市批准快速通道
Merck & Co – known as MSD outside the US and Canada – has said its investigational GLP-1/glucagon receptor co-agonist, efinopegdutide (MK-6024), has demonstrated promising results in nonalcoholic fatty liver disease (NAFLD).
Merck & Co chronic andMSDogressive condition in which fat builds up in the liver. IGLP-1/glucagon receptor co-agonistGLP-1/glucagon receptor coease with efinopegdutide (MK-6024)ver, certain health conditions such as ononalcoholic fatty liver disease (NAFLD)abetes, increase the likelihood of developing NAFLD.
NAFLD is not currently any approved medicine that can treat NAFLD, with treatment options focused on managing the problems associated with the condition.obesitymetabolic syndrometype 2 diabetesNAFLD
The findings, which will be presented at the European AssociNAFLD for the Study of the Liver (EASL) annual congress, include new data from a phase 2a randomised, open-label study evaluating the compound's efficacy in liver fat reduction and safety against Novo Nordisk’s semaglutide in NAFLD patients.
The candidate was recently granted fast track designation from the US 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 thNovo NordisksemaglutideNAFLD
Efinopegdutide will now benefit from the FDA’s fast track process, whiFood and Drug Administration (FDA)ciency of product development and acceleratenonalcoholic steatohepatitis (NASH)us conditions and fill aNAFLDet medical needinflammation
Efinopegdutideociate vice president, globFDAclinical development, Merck Research Laboratories, said: “Significant patient need remains for new treatment options for NASH. This compelling data in patients with NAFLD, along with the recent receipt of fast track designation from the FDA, provides strong rationale for advancing efinopegdutide into phase 2b development for patients with NASH.”
Merck entered into a licensing agreement with Hanmi PharmaceuticalMerck Research Laboratoriesrights to efinopegdutide.NASHNAFLDFDAefinopegdutideNASH
Merckatest announcement regarding the compoundHanmi Pharmaceuticaleek after the Merck’s Prevymis (leterefinopegdutideroved in the US to prevent cytomegalovirus (CMV) disease in high-risk adult kidney transplant recipients.
The company and AstraZeneca’s Lynparza (olaparib) was also granted approval by tMerckA this month letermovirment option for metastatic castratiocytomegalovirus (CMV) diseasemCRPC).
Specifically, thAstraZenecabitLynparza (olaparib)d in combination with Johnson & JoFDAon's anti-androgen therapy Zytiga (abimetastatic castration-resistant prostate cancer (mCRPC)CRPC whose tumours have BRCA mutations.
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