Takeda refiles NDAs with US FDA for diabetes drug alogliptin and combo with pioglitazone

Japan’s largest drugmaker Takeda Pharmaceutical (TYO: 4502) says it has resubmitted two New Drug Applications to the US Food and Drug Administration for alogliptin and the fixed-dose combination therapy alogliptin and the firm’s currently marketed type 2 diabetes drug Actos (pioglitazone).

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 USA for the treatment of type 2 diabetes as an adjunct to diet and exercise. Discovered by Takeda San Diego, 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.

The approval of alogliptin was delayed in 2009, when the FDA called for an additional cardiovascular safety trial. The refiling comes after a recent FDA warning that Actos, when used for more than one year, may be associated with an increased risk of bladder cancer (The Pharma Letter June 16).