ARIAD Pharma (ARIA) Submits NDA for Ponatinib
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ARIAD Pharmaceuticals, Inc. (Nasdaq: ARIA) 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.
ARIAD’s NDA is a rolling submission that includes all sections of the application and will be completed by the addition of a final subset of routine chemistry, manufacturing, and controls (CMC) data that the Company plans to submit to the FDA later in the third quarter. The FDA has communicated to ARIAD that it intends to begin immediate, comprehensive review of the NDA based on today’s rolling submission. ARIAD anticipates approval and commercial launch of ponatinib in the U.S. in the first quarter of 2013.
Results from the ongoing Phase 2 PACE trial of ponatinib reported in June at this year’s annual meeting of the American Society of Clinical Oncology showed that 54 percent of chronic-phase CML patients who were resistant or intolerant to tyrosine kinase inhibitor therapy in the trial, including 70 percent of patients who have a T315I mutation, achieved a major cytogenetic response (MCyR) – the primary endpoint of the PACE trial. Thirty percent of these same patients achieved a major molecular response (MMR). MMR is the primary endpoint of ARIAD’s Phase 3 EPIC trial comparing ponatinib to imatinib that is now underway in newly diagnosed chronic-phase CML patients.
ARIAD’s diagnostic collaborator, MolecularMD Corp., also submitted today a Premarket Approval (PMA) application to the FDA to support commercialization of a companion diagnostic test to identify those CML and Ph+ ALL patients who have the T315I mutation of BCR-ABL.
ARIAD also plans to submit, on schedule, a marketing authorization application (MAA) for ponatinib to the European Medicines Agency (EMA) this quarter.
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ARIAD’s NDA is a rolling submission that includes all sections of the application and will be completed by the addition of a final subset of routine chemistry, manufacturing, and controls (CMC) data that the Company plans to submit to the FDA later in the third quarter. The FDA has communicated to ARIAD that it intends to begin immediate, comprehensive review of the NDA based on today’s rolling submission. ARIAD anticipates approval and commercial launch of ponatinib in the U.S. in the first quarter of 2013.
Results from the ongoing Phase 2 PACE trial of ponatinib reported in June at this year’s annual meeting of the American Society of Clinical Oncology showed that 54 percent of chronic-phase CML patients who were resistant or intolerant to tyrosine kinase inhibitor therapy in the trial, including 70 percent of patients who have a T315I mutation, achieved a major cytogenetic response (MCyR) – the primary endpoint of the PACE trial. Thirty percent of these same patients achieved a major molecular response (MMR). MMR is the primary endpoint of ARIAD’s Phase 3 EPIC trial comparing ponatinib to imatinib that is now underway in newly diagnosed chronic-phase CML patients.
ARIAD’s diagnostic collaborator, MolecularMD Corp., also submitted today a Premarket Approval (PMA) application to the FDA to support commercialization of a companion diagnostic test to identify those CML and Ph+ ALL patients who have the T315I mutation of BCR-ABL.
ARIAD also plans to submit, on schedule, a marketing authorization application (MAA) for ponatinib to the European Medicines Agency (EMA) this quarter.
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