The US Food and Drug Administration (FDA) has approved for marketing Teva Pharmaceutical Industries Ltd.'s (NYSE: TEVA; TASE: TEVA) Trisenox drug as a first-line treatment for acute promyelocytic leukemia. The drug, which is injected, was approved for use in combination with tretinoin for treatment of recently diagnosed low-risk adults with acute promyelocytic leukemia featuring the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.
An extension of the form of the drug, which was already approved for marketing for acute promyelocytic leukemia patients resistant to retinoid and anthracycline chemotherapy has now been approved. Teva obtained the drug as part of its acquisition of Cephalon in 2011. Three months ago, Teva announced that the drug would be granted priority by the FDA, and predicted that a decision would be made in the first quarter of 2018. The FDA grants priority in considering requests for biological drugs or products designed to treat acute situations or unsatisfied medical needs.
“Today’s approval to expand the indication of TRISENOX is a testament to Teva’s commitment to providing solutions to advance cancer care,” said Teva Oncology senior VP and general manager Paul Rittman. “This label expansion represents an important benefit, as TRISENOX is now an FDA-approved first line treatment option for patients with acute promyelocytic leukemia."
Teva, managed by CEO Kare Schultz, has a market cap of $22.4 billion on the New York Stock Exchange and the TASE (Tel Aviv Stock Exchange).
Published by Globes [online], Israel Business News - www.globes-online.com - on January 15, 2018
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