FDA clears resumption of Iclusig sales in USA

The US Food and Drug Administration has approved a revised US Prescribing Information (USPI) and a Risk Evaluation and Mitigation Strategy (REMS) for Iclusig (ponatinib), from Ariad Pharmaceuticals (Nasdaq: ARIA), that allows immediate resumption of its marketing and commercial distribution in the USA.

The leukemia drug that was withdrawn from the market in October on safety concerns (the Pharma Letter November 1) and led to around 160 employees being fired to effect savings for the company. Ariad’s shares jumped 21.5% to $6.71 in afternoon trading on Friday (December 20) following the announcement, but they are still way off the level prior to the revelation of the safety issues, which saw the company lose around $2.5 billion in market capitalization.

Last month, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), which also investigated the drug’s safety, made a number of recommendations to help minimize the risk of blood clots obstructing arteries or veins in patients taking Iclusig (TPL November 23). Iclusing is.

US commercial distribution of Iclusig, Ariad’s only marketed drug, will resume in mid-January. In the meantime, patients can continue to receive Iclusig through emergency and single-patient Investigational New Drug applications. The FDA has approved 350 IND applications for Iclusig since the end of October, the company noted.