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.