DUBLIN, Oct. 9, 2015 /PRNewswire/ -- Allergan plc
(NYSE: AGN) announced that the U.S. Food and Drug
Administration (FDA) has accepted for filing Allergan's
supplemental New Drug Application (sNDA). This filing will expand
the label to include single-dose administration of
DALVANCE® (dalbavancin) for the treatment of
acute bacterial skin and skin structure infections (ABSSSI) in
adults caused by designated susceptible Gram-positive bacteria,
including methicillin-resistant Staphylococcus aureus
(MRSA).
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"With the FDA's acceptance of this supplemental application,
Allergan is one step closer to providing a single-dose option of
DALVANCE which may provide more flexibility to manage serious skin
infections in an outpatient setting," said David Nicholson, Executive Vice President and
President Global Brands Research and
Development, Allergan. "DALVANCE is an important part of
Allergan's anti-infective portfolio focused on addressing
infections in multiple clinical settings to help improve outcomes
for patients and the healthcare system."
The application was based on results from a Phase 3 study
DUR001-303, which compared a single 1500 mg dose of DALVANCE with
the two-dose regimen of 1000 mg followed one week later by 500
mg. Data demonstrated the 1500 mg single dose of DALVANCE
achieved its primary endpoint of non-inferiority to the two-dose
regimen (10% non-inferiority margin) at 48 to72 hours after
initiation of therapy, as determined by a decrease of > 20%
in lesion area relative to the baseline measurement (81.4% vs.
84.2% for the single dose vs. the two dose regimen, respectively;
Difference -2.9; 95% CI: -8.5, 2.8).
DALVANCE was first approved in the U.S. in May 2014 for the treatment of ABSSSI in adults.
DALVANCE is the first and only once-weekly IV antibiotic approved
for the treatment of ABSSSI with a two-dose regimen of 1000 mg
followed one week later by 500 mg.
DALVANCE is marketed in the European Union as XYDALBA™
(dalbavancin) for injection for the treatment of adult patients
with ABSSSI caused by susceptible Gram-positive bacteria, including
MRSA.
About DALVANCE®
DALVANCE® for
injection is a second generation, semi-synthetic lipoglycopeptide,
which consists of a lipophilic side-chain added to an enhanced
glycopeptide backbone. DALVANCE is the first and only IV
antibiotic approved for the treatment of ABSSSI with a two-dose
regimen of 1000 mg followed one week later by 500 mg, each
administered over 30 minutes. DALVANCE demonstrates bactericidal
activity in vitro against a range of Gram-positive bacteria, such
as Staphylococcus aureus (including methicillin-resistant,
also known as MRSA, strains) and Streptococcus pyogenes, as
well as certain other streptococcal species. On May 23, 2014 the FDA approved DALVANCE for the
treatment of adult patients with acute bacterial skin and skin
structure infections (ABSSSI) caused by susceptible Gram-positive
bacteria, including methicillin-resistant Staphylococcus aureus
(MRSA).
INDICATION AND USAGE
DALVANCE (dalbavancin) for
injection is indicated for the treatment of adult patients with
acute bacterial skin and skin structure infections (ABSSSI) caused
by susceptible isolates of the following Gram-positive
microorganisms: Staphylococcus aureus (including
methicillin-susceptible and methicillin-resistant
strains),Streptococcus pyogenes, Streptococcus agalactiae, and
Streptococcus anginosus group (including S. anginosus, S.
intermedius, S. constellatus).
To reduce the development of drug-resistant bacteria and maintain
the effectiveness of DALVANCE and other antibacterial agents,
DALVANCE should be used only to treat infections that are proven or
strongly suspected to be caused by susceptible bacteria.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
DALVANCE is contraindicated in
patients with known hypersensitivity to dalbavancin.
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions
Serious hypersensitivity
(anaphylactic) and skin reactions have been reported with
glycopeptide antibacterial agents, including DALVANCE. Exercise
caution in patients with known hypersensitivity to glycopeptides
due to the possibility of cross-sensitivity. If an allergic
reaction occurs, treatment with DALVANCE should be
discontinued.
Infusion-related Reactions
Rapid intravenous infusion
of DALVANCE can cause reactions, including flushing of the upper
body, urticaria, pruritus, and rash.
Hepatic Effects
ALT elevations with DALVANCE treatment
were reported in clinical trials.
Clostridium difficile-associated
Diarrhea
Clostridium difficile-associated diarrhea
(CDAD) has been reported with nearly all systemic antibacterial
agents, including DALVANCE, with severity ranging from mild
diarrhea to fatal colitis. Evaluate if diarrhea occurs.
Development of Drug-Resistant Bacteria
Prescribing
DALVANCE in the absence of a proven or strongly suspected bacterial
infection is unlikely to provide benefit to the patient and
increases the risk of the development of drug-resistant
bacteria.
ADVERSE REACTIONS
The most common adverse reactions in
patients treated with DALVANCE were nausea (5.5%), headache (4.7%),
and diarrhea (4.4%).
USE IN SPECIFIC POPULATIONS
There have been no
adequate and well-controlled studies with DALVANCE in pregnant or
nursing women. DALVANCE should only be used if the potential
benefit justifies the potential risk in these populations.
In patients with renal impairment whose known creatinine
clearance is less than 30 mL/min and who are not receiving
regularly scheduled hemodialysis, the recommended two-dose regimen
for DALVANCE is 750 mg followed one week later by 375 mg. No dosage
adjustment is recommended for patients receiving regularly
scheduled hemodialysis, and DALVANCE can be administered without
regard to the timing of hemodialysis.
Caution should be exercised when prescribing DALVANCE to
patients with moderate or severe hepatic impairment (Child-Pugh
Class B or C) as no data are available to determine the appropriate
dosing in these patients.
Please see full prescribing information for DALVANCE at
www.dalvance.com.
About ABSSSI
There were more than 4.8 million hospital
admissions of adults with ABSSSI from 2005 through 2011, which
included patients with cellulitis, erysipelas, wound infection and
major cutaneous abscess. In fact, hospital admissions for ABSSSI
significantly increased by 17.3 percent during this timeframe. The
majority of all skin and soft tissue infections in hospitalized
patients are caused by streptococci and Staphylococcus
aureus, and approximately 59 percent of these S.
aureus infections in the U.S. are estimated to be caused
by MRSA. Early and effective treatment of ABSSSI is critical to
optimize patient recovery and for certain patients may also help to
avoid potentially lengthy and costly hospital stays.
About Allergan
Allergan plc (NYSE: AGN),
headquartered in Dublin, Ireland, is a unique, global pharmaceutical
company and a leader in a new industry model – Growth
Pharma. Allergan is focused on developing,
manufacturing and commercializing innovative branded
pharmaceuticals, high-quality generic and over-the-counter
medicines and biologic products for patients around the
world.
Allergan markets a portfolio of best-in-class products that
provide valuable treatments for the central nervous system, eye
care, medical aesthetics, gastroenterology, women's health,
urology, cardiovascular and anti-infective therapeutic categories,
and operates the world's third-largest global generics business,
providing patients around the globe with increased access to
affordable, high-quality medicines. Allergan is an
industry leader in research and development, with one of the
broadest development pipelines in the pharmaceutical industry and a
leading position in the submission of generic product applications
globally.
With commercial operations in approximately 100
countries, Allergan is committed to working with
physicians, healthcare providers and patients to deliver innovative
and meaningful treatments that help people around the world live
longer, healthier lives.
For more information, visit Allergan's website
at www.allergan.com.
Forward-Looking Statement
Statements contained in
this press release that refer to future events or other
non-historical facts are forward-looking statements that reflect
Allergan's current perspective of existing trends and information
as of the date of this release. Except as expressly required by
law, Allergan disclaims any intent or obligation to update these
forward-looking statements. Actual results may differ materially
from Allergan's current expectations depending upon a number of
factors affecting Allergan's business. These factors include, among
others, the difficulty of predicting the timing or outcome of FDA
approvals or actions, if any; the impact of competitive products
and pricing; market acceptance of and continued demand for
Allergan's products; difficulties or delays in manufacturing; and
other risks and uncertainties detailed in Allergan's periodic
public filings with the Securities and Exchange Commission,
including but not limited to Allergan's Quarterly Report on Form
10-Q for the quarter ended March 31,
2015 (such periodic public filings having been filed under
the "Actavis plc" name). Except as expressly required by law,
Allergan disclaims any intent or obligation to update these
forward-looking statements.
CONTACTS:
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Investors:
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Lisa
DeFrancesco
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(862)
261-7152
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Media:
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Mark
Marmur
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(862)
261-7558
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SOURCE Allergan plc