ARIAD Pharma (ARIA) Submits MAA for Ponatinib to EMA
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ARIAD Pharmaceuticals, Inc. (Nasdaq: ARIA) announced the submission of a Marketing Authorization Application (MAA) for its investigational BCR-ABL inhibitor, ponatinib, to the European Medicines Agency (EMA). ARIAD is seeking marketing approval in the European Union of ponatinib in adult patients with resistant or intolerant chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL). The Committee for Medicinal Products for Human Use (CHMP) has granted ARIAD’s request for accelerated assessment of the MAA.
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