FDA delays review of Takeda diabetes therapy

PRNewswire

DEERFIELD — The U.S. Food and Drug Administration has delayed review of Takeda Pharmaceutical’s investigational Type 2 diabetes therapy alogliptin and fixed-dose combination therapy alogliptin/pioglitazone.

The new FDA review dare will be April 25, 2012, Takeda announced in a news release.

“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.,” Recker added.

Alogliptin is a highly potent and highly selective dipeptidyl peptidase IV inhibitor 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, according to the company.

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, the company said. Pioglitazone was approved in 1999 for the treatment of Type 2 diabetes as an adjunct to diet and exercise.