The expansion of Trisenox’s label in the European Union for an acute form of leukemia is now official. Teva Pharmaceutical Industries Ltd (ADR) (NYSE:TEVA) says that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has sanctioned the expansion. What now remains is the approval of retinoic acid, which is used in the treatment of low to intermediate risk acute promyelocytic leukemia (APL). Trisenox’s approval was triggered by the existing academic data, which outlines the benefit of the chemotherapy-free treatment regimen.
Following the CHMP positive opinion, there is a good chance of having the EU approval for expanded use. The expansion approval will give Trisenox a first time position in use for effective treatment of a form of acute leukemia with a regimen that is completely chemotherapy-free.
Trisenox has the approval of the second-line treatment of APL patients
Given the high number of cases of Acute Promyelocytic Leukemia (APL), Trisenox has also been put on the list of approvals for the treatment of second-line APL patients. The treatment is particularly for those who have failed to respond to treatment with retinoids and chemotherapy. APL is a life-threatening type of leukemia. It causes unmanageable bleeding and can kill within a very short time if left untreated.
The annual diagnosis of APL cases in Europe stands at approximately 1,500 to 2,000 people. Its rapid progression has occasioned many mortality cases while affecting close to 30% of the patients in other ways. Hence recognition by the EMA that treating low to intermediate risk APL with a chemo-free regimen of Trisenox is a major plus.
Rob Koremans, President & CEO, Teva Global Specialty Medicines said, “As a company committed to providing medicines and solutions that really make a difference in patients’ lives, we’re pleased to reach this important milestone, and hope soon to be able to offer a chemotherapy-free treatment regimen for APL patients at the point of diagnosis.”
Trisenox received marketing endorsement in 2000
Trisenox has come a long way to this approval, which stemmed from the results of a multicenter study in which 40 deteriorated APL patients received treatment of Trisenox 0.15 mg/kg until bone marrow remission of 60 days. 85% of patients received absolute reduction after two cycles. The overall rate scaled to 87% after the results were put together with those for the 12 patients in a pilot trial.
Nonetheless, the administration of Trisenox must be in the control of an experienced physician who must also follow special monitoring procedures. Meanwhile, Teva was trading at $43.26, an increase of $1.47 or 3.52%.