Bristol-Myers Squibb Receives Complete Response Letter from U.S. Food & Drug Administration for Daclatasvir, an Investigation...
November 26 2014 - 11:34AM
Business Wire
Bristol-Myers Squibb Company (NYSE:BMY) today announced that the
U.S. Food and Drug Administration (FDA) has issued a Complete
Response Letter (CRL) regarding the New Drug Application (NDA) for
daclatasvir, an NS5A complex inhibitor, in combination with other
agents for the treatment of hepatitis C (HCV).
The initial daclatasvir NDA submitted to the FDA focused on its
use in combination with asunaprevir, an NS3/4A protease inhibitor.
Given the withdrawal of asunaprevir by Bristol-Myers Squibb in
October, the FDA is requesting additional data for daclatasvir in
combination with other antiviral agents for the treatment of HCV.
Bristol-Myers Squibb is in discussions with the FDA about the scope
of these data.
“Despite the recent advances in the treatment of hepatitis C
there remain significant areas of unmet high need in this disease
area,” said Francis Cuss, Executive Vice President and Chief
Scientific Officer, R&D, Bristol-Myers Squibb. “Our commitment
remains to make daclatasvir-based regimens available to help these
difficult-to-treat patients achieve cure, and we will continue to
collaborate with the FDA to bring daclatasvir to patients in the
U.S. as quickly as possible.”
Ongoing Daclatasvir Clinical Development
Bristol-Myers Squibb is dedicated to the ongoing clinical
development program for 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. The company continues to progress its daclatasvir
clinical trial program focused on difficult-to-treat patients,
including pre- and post-liver transplant (ALLY-1), HCV patients
co-infected with HIV (ALLY-2) and patients with genotype 3
(ALLY-3). The Phase 3 UNITY studies investigating Bristol-Myers
Squibb’s investigational all-oral fixed-dose-combination DCV-TRIO
regimen (daclatasvir/asunaprevir/beclabuvir) are also ongoing and
include study populations of non-cirrhotic naïve, cirrhotic naïve
and previously treated patients.
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 SquibbMedia:Carrie FernandezOffice:
609-419-5448Cell:
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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