(Reuters) – Ariad Pharmaceuticals Inc said European regulators recommended the approval of its leukemia drug, Iclusig, whose U.S. sale has been suspended due to safety concerns, sending the company’s shares up 24 percent in premarket trading.
The European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended the drug for approval on Friday. European Commission normally endorses the advisory committee within a couple of months.
The EMA recommended that Iclusig should not be used in patients with a history of heart attack or stroke, unless the potential benefits of treatment outweigh the risks, and patients’ heart status should be assessed before starting treatment with the drug.
The news comes as a fresh lease of life for the company, whose market value was almost wiped off after an FDA investigation found that a significant number of patients taking Iclusig developed life-threatening blood clots or narrowing of the veins.
After suspending the sale of the drug due to the concerns, Ariad also said it would cut 40 percent of its workforce to reduce operating expenses.
Ariad shares closed at $ 2.79 on the Nasdaq on Thursday.
(Reporting by Esha Dey in Bangalore; Editing by Don Sebastian)
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- European Commission