ARIAD Pharmaceuticals completes rolling submission of ponatinib NDA with FDA

Sep 28 2012

ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced it has completed the rolling submission of the New Drug Application (NDA) for its investigational BCR-ABL inhibitor, ponatinib, to the U.S. Food and Drug Administration (FDA). ARIAD provided the FDA with remaining chemistry, manufacturing, and controls (CMC) data. 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 has requested accelerated approval and a priority review of the ponatinib application by the FDA.    

"In late July, we submitted the NDA for ponatinib ahead of schedule and, at the request of the FDA, in advance of having the final CMC data. We look forward to continuing our progress towards making ponatinib available to patients with CML and Ph+ ALL," 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."

ARIAD anticipates approval and commercial launch of ponatinib in the U.S. in the first quarter of 2013. Also, the Marketing Authorization Application (MAA) for ponatinib, submitted in August, has been validated by the European Medicines Agency (EMA), commencing their review of the application. The Committee for Medicinal Products for Human Use (CHMP) has granted ARIAD's request for accelerated assessment of the MAA.

Source: ARIAD Pharmaceuticals, Inc.