EMA OKs Continued EU Availability of Ariad’s Iclusig

EU regulators on Friday assured Ariad that its leukemia drug and sole product Iclusig can continue to be sold throughout Europe for its approved indications.

The positive appraisal of Iclusig (ponatinib) by the European Medicines Agency’s (EMA) Committee for Human Medicinal Products gave Ariad a needed lift after the FDA last month ordered the drug removed from U.S. market shelves. The drug’s risk of life-threatening adverse events, including blood clots and narrowing of blood vessels, has been cited in FDA safety alerts.

In consideration of those concerns, the EMA issued a number of recommendations for the drug, including that it should not be used in patients with a history of heart attack or stroke, unless the benefits of taking the drug are greater than the risks.

The EMA plans to continue studying the drug’s safety and might adjust its recommendations appropriately. — Lena Freund

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