CHMP wants more warnings for Ariad's Iclusig

EMA's CHMP recommended stronger warnings concerning risks of blood clots and arterial blockage with use of leukemia drug Iclusig ponatinib from Ariad Pharmaceuticals Inc. (NASDAQ:ARIA). CHMP's opinion endorses a similar recommendation from EMA's Pharmacovigilance Risk Assessment Committee (PRAC) earlier this month.

CHMP said the risk is "likely dose-related," but stopped short of recommending lower doses due to insufficient data and a concern that efficacy would be lost. ...