Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced today
the U.S. Food and Drug Administration (FDA) has accepted for review
the company’s supplemental New Drug Application (sNDA) for the use
of TRISENOX® (arsenic trioxide) injection in combination with
all-trans retinoic acid (ATRA) for induction of remission and
consolidation in patients with newly diagnosed low or intermediate
risk acute promyelocytic leukemia (APL) whose APL is characterized
by the presence of the t(15;17) translocation or PML/RAR-alpha gene
expression.
Currently, TRISENOX® is indicated for induction of remission and
consolidation in patients with acute promyelocytic leukemia (APL)
who are refractory to, or have relapsed from, retinoid and
anthracycline chemotherapy, and whose APL is characterized by the
presence of the t(15;17) translocation or PML/RAR-alpha gene
expression.
“With over 15 years of clinical experience, TRISENOX® is an
important treatment option for APL patients,” said Paul Rittman,
Senior Vice President and General Manager, Teva Oncology. “Teva is
committed to providing solutions that advance cancer care. We are
very pleased that the FDA has accepted the sNDA for priority review
as it brings us one step closer to expanding the label for
TRISENOX® to include use in combination with ATRA for patients with
newly diagnosed low to intermediate risk APL.”
The FDA has accepted the sNDA for priority review with
regulatory action expected in the first quarter of 2018. FDA grants
priority review to applications for drugs or biologics intended to
treat serious conditions and address unmet medical needs. The sNDA
filing includes data from published scientific literature and a
review of Teva’s global safety database for arsenic trioxide.
Please see full accompanying Prescribing Information and safety
information including Boxed Warning regarding: APL differentiation
syndrome, cardiac conduction abnormalities, and electrolyte
monitoring.
TRISENOX® (arsenic trioxide) Injection
Indications
TRISENOX® is indicated for induction of remission and
consolidation in patients with acute promyelocytic leukemia (APL)
who are refractory to, or have relapsed from, retinoid and
anthracycline chemotherapy, and whose APL is characterized by the
presence of the t(15;17) translocation or PML/RAR-alpha gene
expression.
Important Safety Information for TRISENOX®
(arsenic trioxide) Injection
WARNING: APL DIFFERENTIATION SYNDROME, CARDIAC CONDUCTION
ABNORMALITIES, AND ELECTROLYTE MONITORING
APL Differentiation Syndrome: Patients with APL treated
with TRISENOX have experienced symptoms similar to a syndrome
called the retinoic-acid-Acute Promyelocytic Leukemia (RA-APL) or
APL differentiation syndrome, characterized by fever, dyspnea,
weight gain, pulmonary infiltrates and pleural or pericardial
effusions, with or without leukocytosis. This syndrome can be
fatal. High-dose steroids have been administered at the first
suspicion of the APL differentiation syndrome and appear to
mitigate signs and symptoms. At the first signs that could suggest
the syndrome (unexplained fever, dyspnea and/or weight gain,
abnormal chest auscultatory findings or radiographic
abnormalities), immediately initiate high-dose steroids
(dexamethasone 10 mg intravenously BID), irrespective of the
leukocyte count, and continue for at least 3 days or longer until
signs and symptoms have abated. The majority of patients do not
require termination of TRISENOX therapy during treatment of the APL
differentiation syndrome.
Cardiac Conduction Abnormalities: Before initiating
therapy, perform a 12-lead ECG, assess serum electrolytes and
creatinine, correct preexisting electrolyte abnormalities, and
consider discontinuing drugs known to prolong QT interval. Arsenic
trioxide can cause QT interval prolongation and complete
atrioventricular block. QT prolongation can lead to a torsade de
pointes-type ventricular arrhythmia, which can be fatal. The risk
of torsade de pointes is related to the extent of QT prolongation,
concomitant administration of QT prolonging drugs, a history of
torsade de pointes, preexisting QT interval prolongation,
congestive heart failure, administration of potassium-wasting
diuretics, or other conditions that result in hypokalemia or
hypomagnesemia. One patient (also receiving amphotericin B) had
torsade de pointes during induction therapy for relapsed APL with
arsenic trioxide.
Contraindications: TRISENOX is contraindicated in
patients who are hypersensitive to arsenic.
APL Differentiation Syndrome: Nine of 40 patients with
APL treated with TRISENOX, at a dose of 0.15 mg/kg, experienced the
APL differentiation syndrome.
Cardiac Conduction Abnormalities: Torsade de Pointes,
Complete Heart Block, and QT Prolongation: Sixteen of 40 patients
(40%) had at least one ECG tracing with a QTc interval greater than
500 msec. Prolongation of the QTc was observed between 1 and 5
weeks after TRISENOX infusion, and then returned towards baseline
by the end of 8 weeks after TRISENOX infusion. Monitor ECG weekly
and more frequently for clinically unstable patients. For QTc
greater than 500 msec, complete corrective measures and reassess
the QTc with serial ECGs prior to initiating TRISENOX. During
TRISENOX therapy, maintain potassium concentrations above 4 mEq/L
and magnesium concentrations above 1.8 mg/dL. Reassess patients who
reach an absolute QT interval value > 500 msec and immediately
correct concomitant risk factors, if any, while the risk/benefit of
continuing versus suspending TRISENOX therapy should be considered.
The risk may be increased when TRISENOX is coadministered with
medications that can lead to electrolyte abnormalities (such as
diuretics or amphotericin B).
Carcinogenesis: The active ingredient of TRISENOX,
arsenic trioxide, is a human carcinogen. Monitor patients for the
development of second primary malignancies.
Embryo-Fetal Toxicity: TRISENOX can cause fetal harm when
administered to a pregnant woman. One patient who became pregnant
while receiving arsenic trioxide had a miscarriage. Advise pregnant
women of the potential risk to a fetus. Advise females and males of
reproductive potential to use effective contraception during and
after treatment with TRISENOX.
Lactation: TRISENOX is excreted in human milk. Because of
the potential for serious adverse reactions in nursing infants,
discontinue breastfeeding during treatment with TRISENOX.
Laboratory Tests: Electrolyte and glucose levels, as well
as hepatic, renal, hematologic, and coagulation profiles should be
monitored at least twice weekly, and more frequently for clinically
unstable patients during the induction phase and at least weekly
during the consolidation phase.
Drug Interactions: Avoid the concomitant use of TRISENOX
with medications that can prolong the QT/QTc interval or those that
can lead to electrolyte abnormalities. Concomitant use of drugs
that can prolong the QT/QTc interval with TRISENOX may increase the
risk of serious QT/QTc interval prolongation. Electrolyte
abnormalities increase the risk of serious QT/QTc interval
prolongation. Monitor ECGs and electrolytes more frequently in
patients who are unable to avoid concomitant use of these
medications and TRISENOX.
Pediatric Use: In a pediatric study, the toxicity profile
observed in 13 pediatric patients with APL between the ages of 4
and 20 receiving TRISENOX was similar to that observed in adult
patients. Additional drug-related toxicities reported included:
gastrointestinal disorders, metabolic and nutrition disorders,
respiratory disorders, cardiac failure congestive, neuralgia, and
enuresis. One case each of pulmonary edema and caecitis were
considered serious reactions. No children less than 4 years of age
were enrolled in the trial due to the rarity of APL in this age
group.
Patients with Renal Impairment: Exposure of arsenic
trioxide may be higher in patients with severe renal impairment.
Patients with severe renal impairment (creatinine clearance less
than 30 mL/min) should be monitored for toxicity when these
patients are treated with TRISENOX, and a dose reduction may be
warranted. The use of TRISENOX in patients on dialysis has not been
studied.
Patients with Hepatic Impairment: Since limited data are
available across all hepatic impairment groups, caution is advised
in the use of TRISENOX in patients with hepatic impairment. Monitor
patients with severe hepatic impairment (Child-Pugh Class C) who
are treated with TRISENOX for toxicity.
Most Common Adverse Reactions: Most patients experienced
some drug related toxicity, most commonly leukocytosis,
gastrointestinal (nausea, vomiting, diarrhea, and abdominal pain),
fatigue, edema, hyperglycemia, dyspnea, cough, rash or itching,
headaches, and dizziness. These adverse effects have not been
observed to be permanent or irreversible nor do they usually
require interruption of therapy.
TO REPORT SIDE EFFECTS: Contact us at 1-800-896-5855 or
USMedinfo@tevapharma.com
Please see Full Prescribing Information for
TRISENOX® (arsenic trioxide) Injection
About TevaTeva Pharmaceutical Industries Ltd. (NYSE and
TASE: TEVA) is a leading global pharmaceutical company that
delivers high-quality, patient-centric healthcare solutions used by
approximately 200 million patients in over 60 markets every day.
Headquartered in Israel, Teva is the world’s largest generic
medicines producer, leveraging its portfolio of more than 1,800
molecules to produce a wide range of generic products in nearly
every therapeutic area. In specialty medicines, Teva has the
world-leading innovative treatment for multiple sclerosis as well
as late-stage development programs for other disorders of the
central nervous system, including movement disorders, migraine,
pain and neurodegenerative conditions, as well as a broad portfolio
of respiratory products. Teva is leveraging its generics and
specialty capabilities in order to seek new ways of addressing
unmet patient needs by combining drug development with devices,
services and technologies. Teva's net revenues in 2016 were $21.9
billion. For more information, visit www.tevapharm.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
regarding TRISENOX®, which are based on management’s current
beliefs and expectations and are subject to substantial risks and
uncertainties, both known and unknown, that could cause our future
results, performance or achievements to differ significantly from
that expressed or implied by such forward-looking statements.
Important factors that could cause or contribute to such
differences include risks relating to:
- challenges inherent in uncertainty of
obtaining regulatory approvals;
- our specialty medicines business,
including: competition for our specialty products, especially
Copaxone®, our leading medicine, which faces competition from
existing and potential additional generic versions and
orally-administered alternatives; our ability to achieve expected
results from investments in our product pipeline; competition from
companies with greater resources and capabilities; and the
effectiveness of our patents and other measures to protect our
intellectual property rights;
- our business and operations in general,
including: our ability to develop and commercialize additional
pharmaceutical products; manufacturing or quality control problems,
which may damage our reputation for quality production and require
costly remediation; interruptions in our supply chain; disruptions
of our or third party information technology systems or breaches of
our data security; the restructuring of our manufacturing network,
including potential related labor unrest; the impact of continuing
consolidation of our distributors and customers; and variations in
patent laws that may adversely affect our ability to manufacture
our products; our ability to consummate dispositions on terms
acceptable to us; adverse effects of political or economic
instability, major hostilities or terrorism on our significant
worldwide operations; and our ability to successfully bid for
suitable acquisition targets or licensing opportunities, or to
consummate and integrate acquisitions;
compliance, regulatory and litigation matters, including: costs
and delays resulting from the extensive governmental regulation to
which we are subject; the effects of reforms in healthcare
regulation and reductions in pharmaceutical pricing, reimbursement
and coverage; potential additional adverse consequences following
our resolution with the U.S. government of our FCPA investigation;
governmental investigations into sales and marketing practices;
potential liability for sales of generic products prior to a final
resolution of outstanding patent litigation; product liability
claims; increased government scrutiny of our patent settlement
agreements; failure to comply with
complex Medicare and Medicaid reporting and payment
obligations; and environmental risks; and other factors discussed
in our Annual Report on Form 20-F for the year ended December
31, 2016 (“Annual Report”), including in the section captioned
“Risk Factors,” and in our other filings with the U.S.
Securities and Exchange Commission, which are available at
www.sec.gov and www.tevapharm.com. Forward-looking statements speak
only as of the date on which they are made, and we assume no
obligation to update or revise any forward-looking statements or
other information contained herein, whether as a result of new
information, future events or otherwise. You are cautioned not to
put undue reliance on these forward-looking statements.
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version on businesswire.com: http://www.businesswire.com/news/home/20170912005895/en/
Teva Pharmaceutical Industries Ltd.IR Contacts:Kevin C.
Mannix, United States, 215-591-8912Ran Meir, United
States, 215-591-3033Tomer Amitai, Israel, 972 (3)
926-7656orPR Contacts:Iris Beck Codner, Israel, 972 (3)
926-7687Denise Bradley, United States,
215-591-8974Michelle Larkin, United States, 610-786-7335
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