Bristol-Myers Squibb Statement about Asunaprevir in the U.S.
October 07 2014 - 8:30AM
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withdrawn its new drug application (NDA) for asunaprevir, an NS3/4A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 visit http://www.bms.com or follow us
on Twitter at http://twitter.com/bmsnews.
Bristol-Myers Squibb CompanyMedia:Carrie
Fernandez,609-252-4831Cell:
215-859-2605carrie.fernandez@bms.comorInvestors:Ranya Dajani,
609-252-5330ranya.dajani@bms.comorRyan Asay,
609-252-5020ryan.asay@bms.com
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