The European Medicines Agency said Friday that Ariad will be allowed to continue marketing its embattled leukemia drug Iclusig, with extra safety precautions to safeguard patients against an increased risk of blood clots.
Ariad shares are up 37% $3.53 in early Friday trading.
Here's the European announcement:
The CHMP recommends that Iclusig should not be used in patients who have had a heart attack or stroke in the past, unless the potential benefits to them outweigh the risks. In addition, the cardiovascular risks of all patients should be assessed and measures should be taken to reduce risks before starting and during treatment with Iclusig. Patients who have high blood pressure should have their blood pressure controlled, and treatment with Iclusig should be stopped immediately in any patient with signs of blood clots obstructing arteries or veins.
Iclusig was removed from the U.S. market temporarily last month because of new safety showing the drug caused far more blood clots and heart-related side effects than previously believed.
-- Reported by Adam Feuerstein in Boston.
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