U.S. FDA Grants Priority Review For Daklinza (daclatasvir) sNDAs
October 06 2015 - 7:00AM
Business Wire
Three applications are under review for
Daklinza in combination with sofosbuvir with or without
ribavirin to treat chronic hepatitis C patients with decompensated
cirrhosis, post-liver transplant recurrence of HCV, and coinfection
with HIV-1
Bristol-Myers Squibb’s U.S. registration
focus for Daklinza is based on addressing the treatment
needs of challenging HCV patient populations
Bristol-Myers Squibb Company (NYSE:BMY) announced today that the
U.S. Food and Drug Administration (FDA) has accepted for filing and
review three supplemental New Drug Applications (sNDAs) for
Daklinza (daclatasvir), an NS5A replication complex inhibitor, for
use with sofosbuvir with or without ribavirin. The applications are
for the treatment of patients with chronic hepatitis C (HCV)
coinfected with human immunodeficiency virus (HIV-1), patients with
advanced cirrhosis (including decompensated cirrhosis), and for
patients with post-liver transplant recurrence of HCV.
In the U.S., the FDA grants priority review status when an
investigational medicine, if approved, would offer a significant
improvement in the safety or effectiveness of the treatment,
diagnosis, or prevention of serious conditions. The FDA will review
the three Daklinza sNDAs within a six-month timeframe.
“Hepatitis C is not a one-size-fits-all, monolithic disease. Our
focus for the Daklinza-sofosbuvir regimen centers on addressing the
needs of HCV patient subpopulations who need new options even in
light of the extraordinary advances that have occurred in HCV
treatment,” said Douglas Manion, M.D., head of Specialty
Development, Bristol-Myers Squibb. “We look forward to working with
the FDA toward the goal of eventually helping many
difficult-to-treat HCV patients.”
Daklinza was initially approved in the U.S. in July 2015 and is
indicated for use with sofosbuvir for the treatment of patients
with chronic HCV genotype 3 infection. The new sNDAs accepted by
the FDA for review include data from the ALLY-1 and ALLY-2 clinical
trials. ALLY-2 evaluated the once-daily 12-week combination of
Daklinza and sofosbuvir for the treatment of patients with HCV
coinfected with HIV-1, a patient population that historically has
been challenging to treat, in large part due to the complexities of
the overlapping therapeutic regimens used to treat each infection.
ALLY-1 evaluated a 12-week regimen of daclatasvir and sofosbuvir
once-daily with ribavirin for the treatment of patients with HCV
with either advanced cirrhosis or post-liver transplant recurrence
of HCV.
In May 2015, Daklinza with sofosbuvir received FDA Breakthrough
Therapy Designation for HCV genotype 1 patients with advanced
cirrhosis (Child-Pugh Class B or C) and those who develop genotype
1 HCV recurrence post-liver transplant. Breakthrough Therapy
Designation, according to the FDA, is intended to expedite the
development and review of drugs for serious or life-threatening
conditions. The criteria for this designation require preliminary
clinical evidence that demonstrates the drug may have substantial
improvement on at least one clinically significant endpoint over
available therapy.
About Bristol-Myers Squibb in HCV
Bristol-Myers Squibb’s research efforts are focused on advancing
compounds to deliver the most value to HCV patients with high unmet
needs. At the core of our portfolio is Daklinza, a NS5A complex
inhibitor which continues to be investigated in multiple treatment
regimens and in patients with high disease burden.
In July 2014, Japan became the first country in the world to
approve the use of a daclatasvir-based regimen for the treatment of
chronic HCV. Since then, daclatasvir-based regimens have been
approved in more than 50 countries, including the United States,
across Europe, and in numerous other countries in Central and South
America, the Middle East and the Asia-Pacific region.
Indication and Important Safety Information - Daklinza™
(daclatasvir)
INDICATION
Daklinza™ (daclatasvir) is indicated for use with sofosbuvir for
the treatment of patients with chronic hepatitis C virus (HCV)
genotype 3 infection.
Limitations of Use:
- Sustained virologic response (SVR)
rates are reduced in HCV genotype 3-infected patients with
cirrhosis receiving Daklinza in combination with sofosbuvir for 12
weeks.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
- Drugs Contraindicated with
Daklinza: strong inducers of CYP3A that may lead to loss of
efficacy of Daklinza include, but are not limited to:
- Phenytoin, carbamazepine, rifampin, St.
John’s wort (Hypericum perforatum).
WARNINGS and PRECAUTIONS
-- Risk of Adverse Reactions or Loss of Virologic
Response Due to Drug Interactions: Coadministration of Daklinza and
other drugs may result in known or potentially significant drug
interactions. Interactions may include the loss of therapeutic
effect of Daklinza and possible development of resistance, dosage
adjustments for other agents or Daklinza, possible clinically
significant adverse events from greater exposure for the other
agents or Daklinza.
- Serious Symptomatic Bradycardia When
Coadministered with Sofosbuvir and Amiodarone: Post-marketing
cases of symptomatic bradycardia and cases requiring pacemaker
intervention have been reported when amiodarone is coadministered
with sofosbuvir in combination with another direct-acting
antiviral, including Daklinza. A fatal cardiac arrest was reported
with ledipasvir/sofosbuvir.
- Coadministration of amiodarone with
Daklinza in combination with sofosbuvir is not recommended. For
patients taking amiodarone who have no alternative treatment
options, patients should undergo cardiac monitoring, as outlined in
Section 5.2 of the prescribing information.
- Bradycardia generally resolved after
discontinuation of HCV treatment.
- Patients also taking beta blockers or
those with underlying cardiac comorbidities and/or advanced liver
disease may be at increased risk for symptomatic bradycardia with
coadministration of amiodarone.
ADVERSE REACTIONS
- The most common adverse
reactions were (≥ 5%): headache (14%), fatigue (14%), nausea
(8%), and diarrhea (5%).
DRUG INTERACTIONS
- CYP3A: Daklinza is a substrate.
Moderate or strong inducers may decrease plasma levels and effect
of Daklinza. Strong inhibitors (e.g., clarithromycin, itraconazole,
ketoconazole, ritonavir) may increase plasma levels of
Daklinza.
- P-gp, OATP 1B1 and 1B3, and
BCRP: Daklinza is an inhibitor, and may increase exposure to
substrates, potentially increasing or prolonging their adverse
effect.
See Section 7 of the Full Prescribing Information for
additional established and other potentially significant drug
interactions and related dose modification recommendations.
Daklinza in Pregnancy: No data with Daklinza in pregnant
women are available to inform a drug-associated risk. Animal
studies of Daklinza at exposure above the recommended human dose
have shown maternal and embryofetal toxicity. Consider the benefits
and risks of Daklinza when prescribing Daklinza to a pregnant
woman.
Nursing Mothers: Daklinza was excreted into the milk of
lactating rats; it is not known if Daklinza is excreted into human
milk. Consider the benefits and risks to the mother and infant when
breastfeeding.
Please click here for the Daklinza full
prescribing information.
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 www.bms.com or follow us on Twitter at
twitter.com/bmsnews.
Bristol-Myers Squibb Forward Looking Statement
This press release contains "forward-looking statements" as that
term is defined in the Private Securities Litigation Reform Act of
1995 regarding the research, development and commercialization of
pharmaceutical products. Such forward-looking statements are based
on current expectations and involve inherent risks and
uncertainties, including factors that could delay, divert or change
any of them, and could cause actual outcomes and results to differ
materially from current expectations. No forward-looking statement
can be guaranteed. Among other risks, there can be no guarantee
that Daklinza will be approved for the additional indication
mentioned above. Forward-looking statements in this press release
should be evaluated together with the many uncertainties that
affect Bristol-Myers Squibb's business, particularly those
identified in the cautionary factors discussion in Bristol-Myers
Squibb's Annual Report on Form 10-K for the year ended December 31,
2014 in our Quarterly Reports on Form 10-Q and our Current Reports
on Form 8-K. Bristol-Myers Squibb undertakes no obligation to
publicly update any forward-looking statement, whether as a result
of new information, future events or otherwise.
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Bristol-Myers Squibb CompanyMedia:Robert Perry,
609-419-5378cell:
407-492-4616rob.perry@bms.comorInvestors:Ranya Dajani,
609-252-5330ranya.dajani@bms.comorBill Szablewski,
609-252-5894william.szablewski@bms.com
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