Teva's Leukemia Drug SNDA Granted Priority Review By The FDA
Zacks Investment Research | Sep 12, 2017 10:51PM ET
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) announced that the FDA has accepted the supplemental New Drug Application (sNDA) for Trisenox on a priority review basis.
The company is looking to expand the label of Trisenox to include its use in combination with all-trans retinoic acid for the treatment of newly diagnosed patients with low-to-intermediate risk of acute promyelocytic leukemia (APL)
The eligible APL patients should have t(15;17) translocation or PML/RAR-alpha gene expression.
With the FDA granting priority review, a decision is expected in the first quarter of 2018.
We remind investors that Trisenox is currently approved for induction of remission and consolidation in refractory/relapsed APL patients with t(15;17) translocation or PML/RAR-alpha gene expression. The patients should have received prior treatment with retinoid and anthracycline chemotherapy.
The drug is approved in the EU as both first-line and second-line treatment for this indication.
Shares of the company were up almost 4.5% on Tuesday, riding on the momentum following the appointment of H. Lundbeck’s (OTC:HLUYY) chief Kare Schultz as its new CEO and sale of Paragard devices to Cooper Companies, Inc. (NYSE:COO) for $1.1 billion. However, shares of Teva have underperformed the industry so far this year due to challenges in the U.S. generic industry. The company’s shares have plunged 46.7% while the Zacks Investment Research
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