PRINCETON, N.J.--(BUSINESS WIRE
)--Given the rapidly evolving hepatitis C (HCV) treatment landscape in the
U.S., Bristol-Myers Squibb (NYSE:BMY) has decided that it will not
pursue U.S. Food and Drug Administration (FDA) approval of the dual
regimen of daclatasvir and asunaprevir for the treatment of HCV genotype
1b patients in the United States and has therefore withdrawn its new
drug application (NDA) for asunaprevir, an NS3/4A protease inhibitor.
The company will continue to pursue FDA approval of daclatasvir, a
potent, pan-genotypic NS5A complex inhibitor (in vitro
), which is
currently being investigated globally in multiple treatment regimens for
HCV patients with high unmet need.
Bristol-Myers Squibb’s HCV strategy has always been to focus on the
unique unmet medical need of each local market. For example, in Japan we
were pleased to receive regulatory approval for the dual regimen of
daclatasvir and asunaprevir in July, bringing Japanese patients with HCV
the first all-oral, interferon- and ribavirin-free treatment regimen.
The dual regimen was developed to meet the distinct need of the Japanese
patient population, and we believe this treatment has the potential to
play a major role in curing HCV patients in Japan, as well as in other
markets where the HCV patient population is similar to Japan. In the EU,
daclatasvir was recently approved for use in combination with other
medicinal products across genotypes 1, 2, 3 and 4 for the treatment of
HCV infection in adults. Similarly, we believe that daclatasvir-based
regimens have the potential to fill continued unmet medical need in the
U.S. and elsewhere in the world.
We plan to submit additional data for daclatasvir to the FDA from our
ongoing clinical trial program focused on difficult-to-treat patients,
including patients with HCV genotype 3, patients who are pre- and
post-liver transplant, and patients co-infected with HIV. Next month at
the annual meeting of The American Association for the Study of Liver
Diseases (AASLD), we will present new data from several
daclatasvir-based regimens. We look forward to bringing daclatasvir to
patients in the U.S. and will continue to work closely with the FDA to
advance our regulatory application, with the aim of bringing the
investigational product to market as quickly as possible.
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
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