The article discusses the recent Fast Track designation granted by the U.S. Food and Drug Administration (FDA) to Merck’s experimental drug, efinopegdutide, for the treatment of nonalcoholic steatohepatitis (NASH). NASH is a progressive form of fatty liver disease with no approved medications currently available.
The Fast Track designation signifies the FDA’s recognition of the drug’s potential to address an unmet medical need in a serious condition. It expedites the development and review process, allowing for more frequent communication between Merck and the FDA to accelerate the drug’s evaluation.