DUBLIN, Sept. 2, 2015 /PRNewswire/ -- Allergan plc (NYSE:
AGN) today announced the U.S. Food and Drug
Administration (FDA) has approved the company's supplemental
new drug application (sNDA) to update the label for
TEFLARO® (ceftaroline fosamil) for the treatment of
adult patients with acute bacterial skin and skin structure
infections (ABSSSI) and community-acquired bacterial pneumonia
(CABP). The approved label contains new clinical data from two
ABSSSI trials that included patients with baseline
Staphylococcus aureus bacteremia. Bacteremia is the presence
of bacteria in the bloodstream. Bacteremia complicates
infection treatment and in the most serious cases, can be
fatal.
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With this updated label, TEFLARO also is now approved to be
administered by intravenous (IV) infusion in five minutes to one
hour in adult patients 18 years and older.
"The new clinical data in the TEFLARO label will allow for use
in ABSSSI patients with baseline S. aureus bacteremia, the
incidence of which has increased sharply in recent years, and
provides physicians with the ability to treat patients with these
serious infections," said David
Nicholson, Executive Vice President & President, Global
Brands Research and Development, Allergan. "In addition,
with a shorter infusion time TEFLARO provides increased flexibility
in dosing that may allow physicians, nurses and other healthcare
professionals to optimize the delivery of care in hospital and home
settings."
Updated ABSSSI Trial Data
The sNDA approval was based on a subset of data coming from two
identical pivotal trials (CANVAS 1 and 2) comparing ABSSSI patients
treated with TEFLARO monotherapy to patients treated with
vancomycin plus aztreonam. Of the 693 patients in the modified
intent-to-treat (MITT) population in the TEFLARO arm in the two
ABSSSI trials, 20 patients had baseline Staphylococcus
aureus bacteremia (nine cases of methicillin-resistant
Staphylococcus aureus [MRSA] and 11 cases of
methicillin-susceptible Staphylococcus aureus [MSSA]).
Thirteen of these 20 patients (65%) achieved clinical response with
TEFLARO at Day 3 and 18 of 20 patients (90%) were considered
clinical success at Test of Cure. This data is now included in the
clinical trial section of the Teflaro prescribing information.
Updated Dosing Time
TEFLARO can now be administered in 5 minutes to one hour in the
treatment of patients with ABSSSI and CABP due to designated
susceptible pathogens. Recommended dosing for TEFLARO is 600 mg IV
for 5 to 60 minutes by IV every 12 hours for 5 to 14 days for
ABSSSI and 5 to 7 days for CABP.
Patients with renal impairment should receive TEFLARO in a 5 to
60 minute IV infusion every 12 hours at the following dosages:
>50 CrCl (mL/min): 600 mg
>30 to <50 CrCl (mL/min): 400 mg
>15 to <30 CrCl (mL/min): 300 mg
End-stage renal disease (CrCl < 15 mL/min), including
hemodialysis: 200 mg
ABOUT TEFLARO® (ceftaroline
fosamil)
TEFLARO was first approved by the U.S. FDA in October 2010 for the
treatment of adults with CABP and ABSSSI due to designated
susceptible pathogens. TEFLARO is a bactericidal
cephalosporin with activity against both
Gram-positive and Gram-negative pathogens. TEFLARO is
indicated for the treatment of CABP, including cases caused
by Streptococcus pneumoniae , and ABSSSI,
including cases caused by methicillin-resistant Staphylococcus
aureus (MRSA). TEFLARO is the first and only cephalosporin with
activity against MRSA. In clinical trials, TEFLARO was
generally well-tolerated with an adverse event profile consistent
with the cephalosporin class of antibiotics. TEFLARO has been
administered in over 2.3 million days of therapy, treating more
than 350,000 patients.
Forest obtained the worldwide rights (excluding Japan,
where Takeda Pharmaceuticals holds rights) to TEFLARO in
2007 when it acquired Cerexa, Inc., a privately held
biopharmaceutical company. In August 2009, Forest
Laboratories and AstraZeneca (NYSE:AZN) entered into
a definitive collaboration agreement to co-develop and
commercialize ceftaroline fosamil in all markets outside the
U.S., Canada and Japan.
INDICATIONS AND USAGE
TEFLARO is indicated for the treatment of acute ABSSSI caused by
susceptible bacterial isolates of the following Gram-positive and
Gram-negative microorganisms: Staphylococcus aureus
(methicillin-susceptible and -resistant isolates) Streptococcus
pyogenes, Streptococcus agalactiae, Escherichia
coli, Klebsiella pneumoniae and Klebsiella
oxytoca.
TEFLARO is also indicated for the treatment of CABP caused by
susceptible bacterial isolates of the following Gram-positive and
Gram-negative microorganisms: Streptococcus
pneumoniae (including cases with concurrent
bacteremia), Staphylococcus
aureus (methicillin-susceptible isolates
only), Haemophilus influenzae, Klebsiella pneumoniae,
Klebsiella oxytoca and Escherichia
coli.
To reduce the development of drug-resistant bacteria and
maintain the effectiveness of TEFLARO and other antibacterial
drugs, TEFLARO should be used to treat only ABSSSI or CABP that are
proven or strongly suspected to be caused by susceptible
bacteria.
Appropriate specimens for microbiological examination should be
obtained in order to isolate and identify the causative pathogens
and to determine their susceptibility to ceftaroline. When culture
and susceptibility information are available, they should be
considered in selecting or modifying antibacterial therapy. In the
absence of such data, local epidemiology and susceptibility
patterns may contribute to the empiric selection of
therapy.
IMPORTANT SAFETY INFORMATION
Contraindications
- TEFLARO is contraindicated in patients with known serious
hypersensitivity to ceftaroline or other members of the
cephalosporin class. Anaphylaxis and anaphylactoid reactions have
been reported with ceftaroline.
Warnings and Precautions
Hypersensitivity Reactions
- Serious and occasionally fatal hypersensitivity (anaphylactic)
reactions and serious skin reactions have been reported with
beta-lactam antibacterial drugs. Before therapy with TEFLARO is
instituted, careful inquiry about previous hypersensitivity
reactions to other cephalosporins, penicillins, or carbapenems
should be made. Maintain clinical supervision if this product is to
be given to a penicillin- or other beta-lactam-allergic patient,
because cross sensitivity among beta-lactam antibacterial agents
has been clearly established.
- If an allergic reaction to TEFLARO occurs, discontinue TEFLARO
and institute appropriate treatment and supportive measures.
Clostridium difficile-Associated
Diarrhea
- Clostridium difficile-Associated Diarrhea (CDAD) has
been reported for nearly all systemic antibacterial agents,
including TEFLARO, and may range in severity from mild diarrhea to
fatal colitis. Careful medical history is necessary because CDAD
has been reported to occur more than 2 months after the
administration of antibacterial agents. If CDAD is suspected or
confirmed, antibacterials not directed against C. difficile
should be discontinued, if possible.
Direct Coombs' Test Seroconversion
- Seroconversion from a negative to a positive direct Coombs'
test result occurred in 120/1114 (10.8%) of patients receiving
TEFLARO and 49/1116 (4.4%) of patients receiving comparator drugs
in the four pooled Phase 3 trials. No adverse reactions
representing hemolytic anemia were reported in any treatment group.
If anemia develops during or after treatment with TEFLARO,
drug-induced hemolytic anemia should be considered. If drug-induced
hemolytic anemia is suspected, discontinuation of TEFLARO should be
considered and supportive care should be administered to the
patient if clinically indicated.
Development of Drug-Resistant Bacteria
- Prescribing TEFLARO 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
- In the four pooled Phase 3 clinical trials, serious adverse
reactions occurred in 98/1300 (7.5%) of patients receiving TEFLARO
and 100/1297 (7.7%) of patients receiving comparator drugs.
Treatment discontinuation due to adverse reactions occurred in
35/1300 (2.7%) of patients receiving TEFLARO and 48/1297 (3.7%) of
patients receiving comparator drugs with the most common adverse
reactions leading to discontinuation being hypersensitivity for
both treatment groups at a rate of 0.3% in the TEFLARO group and
0.5% in the comparator group.
- No adverse reactions occurred in greater than 5% of patients
receiving TEFLARO. The most common adverse reactions occurring in
>2% of patients receiving TEFLARO in the pooled Phase 3 clinical
trials were diarrhea, nausea, and rash.
Drug Interactions
- No clinical drug-drug interaction studies have been conducted
with TEFLARO. There is minimal potential for drug-drug interactions
between TEFLARO and CYP450
substrates, inhibitors, or inducers; drugs known to undergo active
renal secretion; and drugs that may alter renal blood flow.
Use in Specific Populations
- TEFLARO has not been studied in pregnant women. Therefore,
TEFLARO should only be used during pregnancy if the potential
benefit justifies the potential risk to the fetus.
- It is not known whether ceftaroline is excreted in human milk.
Because many drugs are excreted in human milk, caution should be
exercised when TEFLARO is administered to a nursing woman.
- Safety and effectiveness in pediatric patients have not been
established.
- Because elderly patients, those ≥65 years of age, are more
likely to have decreased renal function and ceftaroline is excreted
primarily by the kidney, care should be taken in dose selection in
this age group and it may be useful to monitor renal function.
Dosage adjustment for elderly patients should therefore be based on
renal function.
- Dosage adjustment is required in patients with moderate (CrCl
>30 to ≤50 mL/min) or severe (CrCl ≥15 to ≤30 mL/min) renal
impairment and in patients with end-stage renal disease (CrCl
<15 mL/min).
- The pharmacokinetics of ceftaroline in patients with hepatic
impairment have not been established.
Please also see the full Prescribing Information at
www.TEFLARO.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 Staphylococcus 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:
Investors:
Lisa
DeFrancesco
(862) 261-7152
Media:
Mark Marmur
(862) 261-7558
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SOURCE Allergan plc