Ariad gains on CHMP Iclusig recommendations

Ariad Pharmaceuticals Inc. (NASDAQ:ARIA) jumped $0.99 (35%) to $3.78 on Friday after EMA's CHMP made several recommendations on the use of Ariad's Iclusig ponatinib to help minimize the risk of occlusive vascular events, but did not recommend the leukemia drug be removed from the European market. CHMP said Iclusig should not be used in patients who have had a heart attack or stroke unless the potential benefits outweigh the risks, and that CV risk factors be "actively managed" before starting Iclusig. Additionally, the committee said hypertension should be controlled during treatment and that patients should be monitored for evidence of vascular occlusion or thromboembolism. CHMP's recommendations are "broadly in line" with recommendations from EMA's Pharmacovigilance Risk Assessment Committee (PRAC), which earlier this month said patients could continue to use Iclusig but with "increased caution" (see BioCentury Extra, Nov. 8).

The European Commission will update Iclusig's product information to reflect CHMP's recommendations. EMA said it is still reviewing data on the benefits and risks of Iclusig. In early November, the agency said it was reviewing data on the risk of arterial thrombosis with the drug. ...