Teva Receives FDA Priority Review for First Line Use of TRISENOX® (arsenic trioxide) in Patients with Low to Intermediate Risk Acute Promyelocytic Leukemia (APL)
- Category: Small Molecules
- Published on Tuesday, 12 September 2017 18:54
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JERUSALEM, Israel I September 12, 2017 I 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.
Teva 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.
SOURCE: Teva Pharmaceutical Industries