Ariad Pharmaceuticals, Inc. (ARIA) Announces Continuation Of Iclusig Review Under The Article 20 Procedure In Europe
7/14/2014 11:10:40 AM
CAMBRIDGE, Mass. & LAUSANNE, Switzerland--(BUSINESS WIRE)--ARIAD Pharmaceuticals, Inc. (NASDAQ:ARIA) today announced that the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has provided the Company with a request for limited additional information regarding Iclusig® (ponatinib) as part of its ongoing review under the Article 20 referral procedure. The PRAC has requested further information regarding proposed dose modifications after achievement of a response and patient monitoring and details concerning a risk management plan. Following ARIAD’s response and input from the agency’s Scientific Advisory Group, the Company expects that the PRAC will complete its review and make final recommendations to the Committee for Medicinal Products for Human Use (CHMP) at its meeting in October 2014.
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