FDA extends review timeline for Onglyza

PRINCETON, N.J. A Type 2 diabetes medication developed by two drug makers will require extensive review by the Food and Drug Administration.

Bristol-Myers Squibb and Astra Zeneca reported Thursday that the FDA has determined it needs additional time to complete the review of the new drug application for Onglyza (saxagliptin). Accordingly, the FDA has extended the Prescription Drug User Fee Act date from April 30, 2009, to July 30, 2009. The NDA for Onglyza was submitted to the FDA on June 30, 2008.

Onglyza is an investigational, selective, reversible inhibitor of the dipeptidyl peptidase-4 enzyme under joint development by Bristol-Myers Squibb and AstraZeneca for the treatment of Type 2 diabetes.

The Onglyza application to the FDA includes use as a monotherapy, as an adjunct to diet and exercise; use in combination with three types of commonly used oral anti-diabetic medications, including metformin, thiazolidinediones and sulfonylureas, when the single agent alone does not provide adequate glycemic control as an adjunct to diet and exercise, and use in initial combination therapy with metformin, as an adjunct to diet and exercise.