Can Iclusig Return To Market? Ariad Sees Path Through Restricted Distribution REMS

 
• By Sue Sutter

Company reluctantly agrees to FDA’s request to suspend sales of ponatinib due to serious thrombotic risks while a narrower label and Risk Evaluation and Mitigation Strategy are negotiated. FDA cites serious adverse vascular event rates of 48% and 24% in Phase I and II ponatinib trials, respectively.

Ariad Pharmaceuticals Inc.’s hopes for restarting sales of Iclusig (ponatinib) hinge on the company’s ability to identify, to FDA’s satisfaction, a patient population for whom the leukemia drug’s benefits outweigh its thrombotic risks and to create an appropriate Risk Evaluation and Mitigation Strategy with a restricted distribution program.

Ariad announced Oct. 31 that it has temporarily suspended marketing and commercial distribution of Iclusig while it negotiates with FDA...

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