Takeda Pharmaceutical Company Limited announced today that
Takeda Global Research & Development Center, Inc., resubmitted two New Drug
Applications (NDA) to the FDA for alogliptin and the fixed-dose combination
therapy alogliptin/pioglitazone, which combines alogliptin with pioglitazone in
a single tablet. The FDA will review the NDA resubmissions within the next six
months. Pioglitazone was approved in 1999 for the treatment of type 2 diabetes
as an adjunct to diet and exercise. Alogliptin is a selective dipeptidyl
peptidase IV inhibitor (DPP-4i) under investigation in the U.S. for the
treatment of type 2 diabetes as an adjunct to diet and exercise. Discovered by Takeda
San Diego, Inc., alogliptin is designed to slow the inactivation of incretin
hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent
insulinotropic peptide), which play a role in regulating blood glucose levels.
"We believe interim results from a cardiovascular
outcomes trial satisfy the FDA's cardiovascular safety requirements to allow
the Agency to complete its review of our NDA, and further support the product
profile of alogliptin," said David Recker, M.D., senior vice president,
clinical science, Takeda Global Research & Development Center. "If
approved, alogliptin/pioglitazone will be the first type 2 diabetes treatment
option in the U.S.
to include both a DPP-4 inhibitor and a thiazolidinedione in a single
tablet."
The NDA resubmissions include interim results from the
EXAMINE ( EX amination of C A rdiovascular Outco M es: Aloglipt IN vs. Standard
of Car E in Patients with Type 2 Diabetes Mellitus and Acute Coronary Syndrome)
study, a cardiovascular outcomes trial requested by the FDA to satisfy the
criteria outlined in the December 2008 "Guidance for Industry: Diabetes
Mellitus -- Evaluating Cardiovascular Risk in New Antidiabetic Therapies to
Treat Type 2 Diabetes." The EXAMINE study was designed to comply with the
Guidance. This randomized, double-blind, placebo-controlled outcomes study continues
to evaluate cardiovascular endpoints following treatment with alogliptin in
addition to standard of care, versus standard of care alone, in patients with
type 2 diabetes and a recent acute coronary syndrome (ACS). Final study results
are expected in 2014.
"The NDA resubmissions mark a significant milestone for
Takeda in the U.S.,
underscoring our deeply held commitment to providing therapeutic options for
patients living with type 2 diabetes," said Robert Spanheimer, M.D., vice
president, medical and scientific affairs, Takeda Pharmaceuticals North
America. "We are confident in the data available for alogliptin, and look
forward to building upon our global expertise in the diabetes therapeutic area."