Ariad gets positive final EC decision on Iclusig

USA-based Ariad Pharmaceuticals (Nasdaq: ARIA) today revealed that the European Commission has endorsed the final opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) on Iclusig (ponatinib) following recommendations made by the Pharmacovigilance Risk Assessment Committee (PRAC).

This concludes the European Article 20 review of Iclusig and is a binding decision for Iclusig to continue to be prescribed in Europe in accordance with its already approved indications. Net global sales of Iclusig were around $55 million for the year ended December 31, 2014, according to the company, when it set out its strategic objectives earlier this month.

“With this final step in the review of Iclusig in Europe now complete, we will continue to focus our efforts on completing pricing and reimbursement in the remaining European countries this year and ensuring that Iclusig is available to all appropriate Philadelphia-chromosome positive leukemia patients,” said Jonathan Dickinson, general manager, Ariad Pharmaceuticals (Europe). “This thorough review validates Iclusig’s indications and the favorable benefit-risk balance of Iclusig for patients with resistant or intolerant CML,” he noted.