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News breaking: 2017-09-13

Teva Receives FDA Priority Review for First Line Use of TRISENOX® (..

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Teva Receives FDA Priority Review for First Line Use of TRISENOX® (arsenic trioxide) in Patients with Low to Intermediate Risk Acute Promyelocytic Leukemia (APL)
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
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
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
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
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
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
View source version on businesswire.com: http://www.businesswire.com/news/home/20170912005895/en/
Source: Teva Pharmaceutical Industries Ltd.

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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