Takeda Pharmaceutical Company Limited (Takeda) and its wholly-owned subsidiary, Takeda Global Research & Development Center, Inc., U.S., today announced that the company received notification from the U.S. Food and Drug Administration (FDA) that its review of investigational type 2 diabetes therapy alogliptin, and thus the fixed-dose combination therapy alogliptin/pioglitazone, will be delayed. The new Prescription Drug User Fee Act (PDUFA) action date has been set for April 25, 2012. The FDA originally assigned a PDUFA action date of January 25, 2012.
"Takeda is confident in alogliptin and alogliptin/pioglitazone as potential therapeutic options for the millions of patients living with type 2 diabetes," said David Recker, M.D., senior vice president, clinical science, Takeda Global Research & Development Center, Inc., U.S. "We will work closely with the FDA to determine the appropriate next steps, and are dedicated to continuing our efforts to bring these important therapies to market in the U.S."
Alogliptin is a highly potent and highly 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 roles in regulating blood glucose levels. Alogliptin/pioglitazone combines alogliptin with pioglitazone, two complementary agents with distinct mechanisms of action, and if approved, will be the first type 2 diabetes treatment option in the U.S. to include both a DPP-4 inhibitor and a thiazolidinedione (TZD) in a single tablet. Pioglitazone was approved in 1999 for the treatment of type 2 diabetes as an adjunct to diet and exercise.
There is no change in Takeda's fiscal 2011 financial outlook, which was announced on November 4, 2011, because of this delay.
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