Bristol-Myers Squibb Company
) 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
) are also developing therapies targeting the highly lucrative
Bristol-Myers carries a Zacks Rank # 2 (Buy).
Better-ranked stocks in the biopharma space include
). Both stocks carry a Zacks Rank #1 (Strong Buy).
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