Ariad Announces Submission of New Drug Application for Ponatinib to the U.S. Food and Drug Administration
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced the submission of a New Drug Application (NDA) for its investigational BCR-ABL inhibitor, ponatinib, to the U.S. Food and Drug Administration (FDA). ARIAD is seeking U.S. marketing approval of ponatinib in patients with resistant or intolerant chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL). The Company is seeking accelerated approval for ponatinib by the FDA and has requested a priority review of the application.
“The NDA submission for ponatinib is a major achievement for ARIAD and brings us another step closer to making ponatinib available to patients with CML and Ph+ ALL. We are ahead of schedule in the submission of our NDA to the FDA and have taken advantage of the rolling submission process, at the Agency's request, to submit essentially a complete file early in the third quarter,” stated Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. “If approved, we believe that ponatinib will become an important new medicine for CML and Ph+ ALL patients who have become resistant or intolerant to prior tyrosine kinase inhibitor therapy.”
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