百时美施贵宝（BMS）4月7日宣布，已向FDA提交了实验性丙肝药物daclatasvir（DCV）和asunaprevir（ASV）的新药申请（NDA），daclatasvir是一种实验性NS5A复制复合物抑制剂，asunaprevir则是一种实验性NS3蛋白酶抑制剂。NDAs中所包含的数据，支持了丙肝鸡尾酒疗法（全口服方案，daclatasvir+asunaprevir，即DCV+ASV）用于基因型1b丙型肝炎（HCV）的治疗。此外，DCV的NDA，也寻求批准daclatasvir与其他制剂联合用于多种基因型HCV的治疗。目前，欧洲药品管理局（EMA）正在审查daclatasvir的上市许可申请（MAA），同时daclatasvir和asunaprevir的NDAs也正在接受日本监管机构的审查。

此前，FDA已授予丙肝鸡尾酒疗法（DCV+ASV）突破性疗法认定。而去年，鸡尾酒疗法（全口服3DAA方案，DCV/ASV/BMS-791325）也获得了突破性疗法认定，百时美计划于2015年第一季度向FDA提交3DAA方案的监管文件。

目前，丙肝治疗领域竞争十分激烈。吉利德（Gilead）开发的丙肝新药Sovaldi（sofosbuvir）已于2013年12月和2014年1月获FDA和欧盟批准，该药是首个获批可用于C型肝炎全口服治疗方案的药物，在用于特定基因型慢性丙型肝炎治疗时，可消除对传统注射药物干扰素（IFN）的需求。同时，吉利德已于2014年2月向FDA提交了鸡尾酒疗法（ledipasvir/sofosbuvir）的监管文件。

此外，艾伯维（AbbVie）也正在稳步推进其丙肝鸡尾酒疗法，今年3月公布的数据表明，该公司开发的丙肝鸡尾酒疗法（ABT-450/ritonavir/ABT-267/ABT-333）对基因型1b丙型肝炎的治愈率几乎达到了100%。

英文原文：Bristol-Myers Squibb Submits NDAs for Daclatasvir and Asunaprevir to US FDA for the Treatment of Hepatitis C

Monday, April 7, 2014 8:00 am EDT

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) announced today that they have submitted new drug applications (NDAs) with the U.S. Food and Drug Administration (FDA) for the investigational products daclatasvir (DCV), an NS5A replication complex inhibitor, and asunaprevir (ASV), a NS3 protease inhibitor. The data submitted in the NDAs support the use of DCV+ASV in patients with genotype 1b hepatitis C (HCV). The DCV NDA also seeks approval for use of this compound in combination with other agents for multiple genotypes. The submissions are subject to FDA review for acceptance for filing.

“These FDA submissions represent a major step towards offering daclatasvir-based regimens to U.S. HCV patients, many of whom continue to have high unmet medical needs,” said Brian Daniels, MD, senior vice president, Global Development and Medical Affairs, Research and Development, Bristol-Myers Squibb. “We are excited to have achieved this milestone and, looking forward, will continue to innovate and invest in daclatasvir in a range of patient types and regimens.”

These submissions follow the recent announcement that the FDA granted the investigational DCV Dual Regimen (DCV+ASV) Breakthrough Therapy Designation. In 2013, the investigational all-oral 3DAA Regimen (daclatasvir/asunaprevir/BMS-791325) also received Breakthrough Therapy Designation, and the company anticipates submitting this regimen for FDA review in Q1 2015.

In January 2014, the European Medicines Agency (EMA) validated the company’s marketing authorization application for the use of DCV in combination with other agents for the treatment of adults with HCV with compensated liver disease, including genotypes 1, 2, 3, and 4, and this application is under accelerated review. In addition, NDAs for DCV and ASV are under priority review by Japan’s Pharmaceutical and Medical Devices Agency for patients with chronic HCV genotype 1b, classified as either interferon-ineligible naïve/intolerant or non-responders to interferon and ribavirin.

ab0ut Hepatitis C

Hepatitis C is a virus that infects the liver and is transmitted through direct contact with infected blood and blood products. Approximately 170 million people worldwide are infected with hepatitis C, with an estimated 2.7–3.9 million chronically infected in the United States. Up to 90 percent of those infected with hepatitis C will not spontaneously clear the virus and will become chronically infected. According to the World Health Organization, up to 20 percent of people with chronic hepatitis C will develop cirrhosis; of those, up to 25 percent may progress to liver cancer.

ab0ut Bristol-Myers Squibb’s HCV Portfolio

Bristol-Myers Squibb’s research efforts are focused on advancing late-stage compounds to deliver the most value to patients with hepatitis C. At the core of our pipeline is daclatasvir (DCV), an investigational NS5A replication complex inhibitor that has been studied in more than 5,500 patients as part of multiple direct-acting antiviral (DAA) based combination therapies. DCV has shown a low drug-drug interaction profile, supporting its potential use in multiple treatment regimens and in people with co-morbidities.

DCV is currently being studied in the ongoing Phase III UNITY Program, where it is being investigated as part of an all-oral 3DAA Regimen (daclatasvir/asunaprevir/BMS-791325). Study populations include non-cirrhotic naïve, cirrhotic naïve and previously treated patients. The 3DAA Regimen is being studied as a fixed-dose-combination treatment with twice daily dosing.

Daclatasvir is also being investigated in combination with sofosbuvir in high unmet need patients, such as pre- and post-transplant patients, HIV/HCV co-infected patients, and patients with genotype 3, as part of the ongoing Phase III ALLY Program.

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