FDA Designation for Bristol-Myers Candidate - Analyst Blog


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Bristol-Myers Squibb Company ( BMY ) announced that the U.S. Food and Drug Administration (FDA) granted breakthrough therapy designation to its combination of daclatasvir and asunaprevir, which is being developed for treating patients suffering from genotype Ib chronic hepatitis C virus (HCV). The U.S. regulatory body granted the designation to the all-oral combination of daclatasvir and asunaprevir on the basis of data from the ongoing phase III program on the regimen.

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. The designation should help expedite the development and review process of the candidate.

The designation is granted to potential new treatments for serious or life-threatening diseases or conditions where the initial clinical data shows that the treatment has the potential to demonstrate substantial improvement on one or more clinically significant endpoints compared to existing treatments. We note that this is the second breakthrough therapy designation for a regimen including daclatasvir. In 2013, the all-oral combination of daclatasvir, asunaprevir and BMS-791325 received a similar designation. The regimen is being evaluated as a fixed-dose-combination therapy for treating HCV.

Bristol-Myers is highly optimistic of the potential of the combination therapy targeting the highly lucrative HCV market. The Japanese approval for the all-oral combination regimen was sought last year. Bristol-Myers is also seeking EU approval of daclatasvir combined with other agents for treating chronic hepatitis C.

Apart from Bristol-Myers, many established players like AbbVie ( ABBV ) are targeting the lucrative HCV space. The HCV market saw the arrival of a potential blockbuster treatment, Gilead Sciences, Inc. 's ( GILD ) Sovaldi, in December last year. The drug's initial sales have been very encouraging.

Bristol-Myers, a biopharmaceutical company, carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biopharma space include Alexion Pharmaceuticals, Inc. ( ALXN ) and Gilead Sciences. Both stocks carry a Zacks Rank #1 (Strong Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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