US FDA sets PUDFA date for Takeda diabetes drug alogliptin and fixed-dose alogliptin/pioglitazone

The US subsidiary of Japan’s largest drugmaker Takeda Pharmaceutical (TYO: 4502) said yesterday that the US Food and Drug Administration has assigned a Prescription Drug User Fee Act (PDUFA) action date of January 25, 2012 for the review of its investigational type 2 diabetes therapy alogliptin, and the fixed-dose combination therapy alogliptin/pioglitazone, which combines alogliptin with pioglitazone in a single tablet.

Takeda refilled for approval of the two products earlier this year (The Pharma Letter July 270, after failing to gain US regulatory approval to market the products in 2009, when the FDA issued a complete-response letter saying the company must provide more data on cardiovascular risks. Approval of alogliptin in Europe is also delayed until 2012.

Currently, the FDA is reviewing the New Drug Applications for the investigational therapies, which the agency has categorized as Class 2 responses, requiring up to six months for review. 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. Pioglitazone was approved in 1999 for the treatment of type 2 diabetes as an adjunct to diet and exercise. 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 (TZD) in a single tablet.