Israel’s Teva Pharmaceutical Industries has received positive opinion from European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) to extend indication of Trisenox for treatment of low-to intermediate risk acute promyelocytic leukemia (APL).
The extension is meant for use in newly diagnosed low to intermediate risk APL in combination with retinoic acid.
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The life-threatening type of leukemia APL can cause uncontrollable bleeding and can kill within hours or days if not treated.
About 1,500 to 2,000 people in Europe are diagnosed with APL every year.
In combination with retinoic acid, Trisenox has shown a high overall survival rate and is currently indicated for second line treatment of patients, who have not responded to treatment with retinoids and chemotherapy.
The CHMP positive opinion serves as a formal recommendation to grant marketing authorisation for an extended indication for first line treatment for Trisenox.
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By GlobalDataThe European Commission, which has authority to approve medicines for use in the 28 countries of the European Union along with Norway, Liechtenstein and Iceland, will now review the recommendation.
Teva Global Specialty Medicines president and CEO Rob Koremans 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.
“Recognising the high unmet patient need in this orphan disease, we’ve put everything in place to obtain the label extension for this life-saving treatment.”
People with APL are especially susceptible to developing bruises, small red dots under the skin (petechiae), nosebleeds, bleeding from the gums, blood in the urine, or excessive menstrual bleeding.
