FDA Grants Breakthrough Therapy Designation for Treatment of Chronic HCV
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Merck Receives Breakthrough Therapy Designation for MK-5172/MK-8742, an Investigational Oral Combination Regimen for the Treatment of Chronic Hepatitis C Virus (HCV) Infection
WHITEHOUSE STATION, N.J., Oct 22, 2013 (BUSINESS WIRE) — Merck MRK +0.17% , known as MSD outside the United States and Canada, announced today that the U.S. 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, Washington D.C., Nov. 1-5.
“The designation of MK-5172/MK-8742 as a Breakthrough Therapy for chronic hepatitis C is an important milestone for Merck,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “There remains significant unmet medical need in hepatitis C, and we are looking forward to working with the FDA to advance this program as quickly as we can to bring this investigational combination to HCV specialists and their patients.”
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