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Bristol-Myers Squibb Requests FDA Approval of Daclatasvir and Asunaprevir

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Bristol-Myers Squibb has submitted New Drug Applications asking the U.S. Food and Drug Administration (FDA) to approve its experimental hepatitis C virus (HCV) NS5A inhibitor daclatasvir and HCV protease inhibitor asunaprevir, the company announced this week.

Daclatasvir and asunaprevir -- already designated as an FDA "breakthrough therapy" -- has shown good activity against HCV subtype 1b. The company previously requested regulatory approval in Japan, where this viral subtype predominates. Adding a third drug, the non-nucleoside polymerase inhibitor BMS-791325, cured most people with HCV subtypes 1a or 1b. Daclatasvir has also demonstrated very high response rates in combination with Gilead's polymerase inhibitor sofosbuvir.

Below is an edited excerpt from a Bristol-Myers Squibb press release describing the NDA submission.

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

U.S. application submission marks third major daclatasvir regulatory milestone globally, follows E.U. and Japan  

Princeton, N.J. -- April 7, 2014 -- 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.

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 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 naive 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.

4/9/14

Source

Bristol-Myers Squibb. Bristol-Myers Squibb Submits NDAs for Daclatasvir and Asunaprevir to US FDA for the Treatment of Hepatitis C. Press release. April 7, 2014.