ARIAD Announces FDA Acceptance of NDA Filing for Ponatinib
Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that the U.S.
Food and Drug Administration (FDA) has accepted for filing the New Drug
Application (NDA) for accelerated review of ARIAD's investigational
BCR-ABL inhibitor, ponatinib,
in patients with resistant or intolerant chronic myeloid leukemia (CML)
or Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+
ALL). The FDA also has granted ARIAD's request for Priority Review,
which is given to investigational medicines that have the potential for
providing significant improvement in the treatment, prevention, or
diagnosis of a disease. The FDA has established an action date of March
27, 2013 under the Prescription Drug User Fee Act (PDUFA).