Bristol-Myers Seeks FDA Approval for HCV Candidates

Bristol-Myers Squibb Company (BMY) announced that it has filed new drug applications (NDAs) with the U.S. Food and Drug Administration (FDA) for hepatitis C virus (HCV) candidates, daclatasvir (DCV) and asunaprevir (ASV). While daclatasvir belongs to a new class of drugs- NS5A inhibitors- asunaprevir is a NS3 protease inhibitor.

Bristol-Myers is looking to get the combination of DCV and ASV (an all-oral, interferon and ribavirin-free regimen) approved in the U.S. for treating patients with genotype 1b HCV on the basis of data submitted in the applications. Furthermore, the biopharma major is looking to get DCV approved combined with other agents for multiple genotypes of the virus on the basis of data submitted in the DCV NDA.

The combination of DCV and ASV was granted a breakthrough therapy designation by the FDA earlier in the year for the genotype 1b HCV indication. The designation will help expedite the development and review process of the regimen. In 2013, the all-oral combination of daclatasvir, asunaprevir and BMS-791325 received a similar designation. U.S. approval for the combination will be sought in the first quarter of 2015.

Bristol-Myers stated in its press release that HCV affects approximately 170 million patients worldwide with a significant number being afflicted by the disease in the U.S. alone.

We note that Bristol-Myers is looking to get DCV approved in the EU as well in combination with other agents for treating adults suffering from HCV with compensated liver disease, inclusive of genotypes 1, 2, 3, and 4. The application is under accelerated review in the EU. Bristol-Myers is also looking to get the combination of DCV and ASV approved in Japan for treating adults suffering from genotype 1b version of HCV. The patients were either ineligible for or intolerant to interferon therapy or non-responders to the same.

Bristol-Myers is highly optimistic of the potential of the combination therapy. Companies like AbbVie (ABBV) are also developing therapies targeting the highly lucrative HCV market.

Bristol-Myers carries a Zacks Rank # 2 (Buy). Better-ranked stocks in the biopharma space include Alkermes (ALKS) and Alexion Pharmaceuticals (ALXN). Both stocks carry a Zacks Rank #1 (Strong Buy).

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