The FDA has rescinded breakthrough therapy designation status from Bristol-Myers Squibb for daclatasvir for the treatment of hepatitis C virus infection, according to a statement from the manufacturer.
The FDA has rescinded breakthrough therapy designation status from
Bristol-Myers Squibb for daclatasvir for the treatment of hepatitis C
virus infection, according to a statement from the manufacturer.
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.
– Bristol-Myers Squibb Co on Wednesday said U.S. regulators had
declined to approve the use of its experimental treatment for hepatitis
C, daclatasvir, in combination with other antiviral drugs.
Bristol-Myers said it had
initially sought permission from the U.S. Food and Drug Administration
to market the drug, a so-called NS5A inhibitor, in combination with
asunaprevir, one of the New York-based company’s experimental medicines.
Bristol-Myers abandoned its U.S. marketing application for asunaprevir
in October because of potential competition from more potent drugs,
leaving the FDA without data to gauge the effectiveness of daclatasvir
as part of a combination regimen.
In a bid to widen access to its hepatitis C drug, Bristol-Myers Squibb has begun talks with health authorities in 90 countries and generic
drug makers, according to a brief statement posted on the drug maker’s
web site late last week.
Bristol did not offer many specifics, other than to say it is
pursuing licensing and tiered pricing, which refers to offering a drug
at a different price in different countries.
The move comes as pricing over hepatitis C treatments – notably, a pair of medications sold by Gilead Sciences – has helped to fuel a growing controversy
over the cost of medicines. In the U.S., for instance, the Sovaldi
treatment costs $1,000 a pill, or $84,000 for a 12-week regimen, while a
newer treatment called Harvoni is priced at roughly $95,000. The prices have alarmed Medicaid and private insurers.
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
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A treatment estimated to cure chronic hepatitis C infection in up to
99% of cases when used in combination with other drugs has been launched
in the UK.
Described as “an important step forward towards the
holy grail of highly effective, short, tolerable and interferon-free
therapy”, daclatasvir is the third new treatment for hepatitis C to be
launched in 2014, following sofosbuvir and simprevir.
“This is the first in its class and is therefore a potent and needed
weapon in an armoury that is improving all the time and presents an
opportunity to eliminate hepatitis C within no more than 15
years,” Charles Gore, chief executive of the charity, the Hepatitis C