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Bristol-Myers Squibb Submits NDAs for Daclatasvir and Asunaprevir to US FDA for the Treatment of Hepatitis C
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U.S. application submission marks third major daclatasvir regulatory milestone globally, follows E.U. and Japan
Monday, April 7, 2014 8:00 am EDT
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 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"
"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.
About 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.
About 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 5500 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.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover develop and deliver innovative medicines that help patients prevail over serious diseases. For more information please visit http://www.bms.com or follow us on Twitter at http://twitter.com/bmsnews.
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