FDA授予默沙东丙型肝炎全口服方案MK-5172/MK-8742突破性疗法认定

默沙东（Merck & Co）宣布，FDA已授予实验性组合药物MK-5172/MK-8742突破性疗法认定，开发用于治疗慢性丙型肝炎病毒感染。

MK-5172/MK-8742是一种全口服组合方案，MK-5172是一种实验性HCV NS3/4A蛋白酶抑制剂，MK-8742则是一种实验性HCV NS5A复制复合物抑制剂。

目前，默沙东正在开展一项IIb期临床试验（C-WORTHY Study），在基因型1感染者中评价MK-5172/MK-8742。该项研究的中期数据，将提交至11月1日-11月5日在华盛顿举行的第64届美国肝病年会。

慢性丙型肝炎是默沙东研发的优先重点。目前，该公司正在一个广泛的临床项目中评价MK-5172和MK-8742，包括多种HCV基因型感染初治患者、治疗失败的患者、以及其他重要的HCV亚群，如肝硬化患者和HCV/HIV合并感染着。

英文原文：FDA grants Merck’s hepatitis C treatment breakthrough designation

WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), 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.”

According to the FDA, the designation of an investigational drug as a Breakthrough Therapy is intended to expedite the development and review of a candidate that is planned for use, alone or in combination, to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.

Chronic hepatitis C is a priority focus of research and development at Merck. MK-5172 and MK-8742 are being investigated in a broad clinical program that includes studies in patients with multiple HCV genotypes who are treatment-naïve, treatment failures as well as other important HCV subpopulations such as patients with cirrhosis and those co-infected with HIV.