Teva receives CHMP recommendation for new approval of Trisenox

Teva has announced that Europe's Committee for Medicinal Products for Human Use (CHMP) has recommended that its cancer drug Trisenox be approved in a new indication.

The European Medicines Agency committee has adopted a positive opinion recommending an indication extension of Trisenox for use in newly-diagnosed low-to-intermediate-risk acute promyelocytic leukaemia (APL) in combination with retinoic acid.

Trisenox has been associated with a very high overall survival rate among sufferers of this rare and deadly disease, with almost no relapses after more than four years of median follow-up. If approved, it would mark the first time that a form of acute leukaemia can be effectively treated with a wholly chemotherapy-free regimen.

APL can cause uncontrollable bleeding and lead to death within hours or days if left untreated. In Europe, approximately 1,500 to 2,000 people are diagnosed with APL each year.

Rob Koremans, president and chief executive officer of Teva's global specialty medicines business, said: "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."

A final decision from the European Commission on the approval of the drug is expected before the end of the year.

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