Teva Pharma: CHMP Adopts Positive Opinion For Extended Indication Of Trisenox

(RTTNews) - Teva Pharmaceutical Industries Ltd., (TEVA) announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending an indication extension of Trisenox (arsenic trioxide). The indication extension is for use in newly diagnosed low to intermediate risk Acute Promyelocytic Leukemia in combination with retinoic acid.

The company said, if the European Commission approves the label extension, it would mark the first time that a form of acute leukemia can be effectively treated with a regimen that is entirely chemotherapy-free. A final decision by the European Commission is expected by the end of the year.