FDA grants Merck’s hepatitis C treatment breakthrough designation
US pharma giant Merck & Co (NYSE:MRK) has announced that the US Food and Drug Administration (FDA) has granted MK-5172/MK-8742 Breakthrough Therapy designation for treatment of chronic hepatitis C virus infection.
MK-5172/MK-8742 is an all-oral combination regimen consisting of MK-5172, an investigational HCV NS3/4A protease inhibitor, and MK-8742, an investigational HCV NS5A replication complex inhibitor. Interim data from an ongoing Phase IIB clinical trial evaluating MK-5172/MK-8742 in genotype 1 infected patients (C-WORTHY Study) is scheduled to be presented at the 64th American Association for the Study of Liver Disease Annual Meeting, in Washington, next month.
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