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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 over labeling changes that would further narrow the kinase inhibitor’s...

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