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CHMP wants more warnings for Ariad's Iclusig

October 25, 2014 12:56 AM UTC

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. ...