Ariad may be able to continue EU Iclusig sales

Ariad jumps as company says EU regulators may be willing to keep its cancer drug on the market

Associated Press

NEW YORK (AP) -- Ariad Pharmaceuticals said Friday that advisers to European Union regulators think its cancer drug Iclusig should stay on the market despite the blood clot risks that resulted in the drug being taken off the market in the U.S.

The Cambridge, Mass., company said Friday that the Committee for Human Medicinal Products made a series of recommendations for prescribing and using Iclusig to help minimize the side effects associated with the drug. The committee did not say sales of Iclusig should be suspended. Iclusig is used to treat two rare types of leukemia. It is a pill taken once per day, and it is Ariad's only approved product.

Shares of Ariad Pharmaceuticals Inc. rose 80 cents, or 29 percent, to $3.59 in morning trading.

According to Ariad, the committee said Iclusig should not be used in patients with a history of heart attack or stroke unless benefits of treatment are expected to outweigh the risks. It also said patients' cardiovascular status should be assessed before and during treatment, and risk factors should be managed and monitored. The panel said physicians should also monitor high blood pressure and consider stopping treatment if patients' blood pressure gets too high. It also said patients should be monitored for evidence of vascular blockage or thromboembolism, and treatment should be stopped if evidence of those problems is found.

European Union regulators approved Iclusig in July.

The Food and Drug Administration approved Iclusig in December 2012. In October, Ariad disclosed a higher rate of side effects from Iclusig related to blood clots. At the end of the month the company suspended all sales, and the Food and Drug Administration said large numbers of patients treated with the drug had later experienced suffered serious side effects, including heart attacks and strokes. Some patients died as a result.

Shares of Ariad have lost 83.7 percent of their value since Oct. 8.

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