Ariad Pharmaceuticals, Inc. Announces Recommendation For Iclusig By The Pharmacovigilance Risk Assessment Committee Of The European Medicines Agency
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 concluded its review of Iclusig® (ponatinib) under the Article 20 referral procedure and has recommended that Iclusig continue to be used in Europe in accordance with its already approved indications.
“We are grateful for the rigorous and in-depth review provided by the PRAC and the Scientific Advisory Group for Oncology,” stated Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. “The PRAC recommendation provides insightful guidance to healthcare professionals and patients regarding the use of Iclusig in patients with Ph+ leukemias and importantly, leaves the original Iclusig indication statement unchanged. We look forward to consideration and adoption of these recommendations by the CHMP later this month and authorization by the European Commission by the end of the year.”
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“We are grateful for the rigorous and in-depth review provided by the PRAC and the Scientific Advisory Group for Oncology,” stated Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. “The PRAC recommendation provides insightful guidance to healthcare professionals and patients regarding the use of Iclusig in patients with Ph+ leukemias and importantly, leaves the original Iclusig indication statement unchanged. We look forward to consideration and adoption of these recommendations by the CHMP later this month and authorization by the European Commission by the end of the year.”
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