EMA committee recommends Iclusig remain on market

EMA's Pharmacovigilance Risk Assessment Committee (PRAC) said patients and healthcare professionals may continue to use leukemia drug Iclusig ponatinib from Ariad Pharmaceuticals Inc. (NASDAQ:ARIA), but with "increased caution" and careful monitoring for thromboembolism and vascular occlusion. PRAC recommended updating Iclusig's product information to include strengthened warnings on the cardiovascular risk and guidance on optimizing CV therapy prior to starting Iclusig. EMA's CHMP will consider PRAC's recommendation at its Nov. 18-21 meeting. Last week, EMA said it was reviewing data on the risk of arterial thrombosis with Iclusig. ...