Bristol-Myers Squibb diabetes drug accepted for FDA review

Bristol Myers-Squibb has had its application for a Food and Drug Administration (FDA) review of one of its diabetes treatments accepted by the regulator.

The FDA is to evaluate the company’s new drug application for Onglyza, an extended-release tablet-based dipeptidyl peptidase-4 inhibitor, as a potential combination treatment with metformin HCl for type 2 diabetes mellitus.

This application was originally submitted on December 29th 2009 and is one of a number of regulatory reviews to which the drug is currently being subjected.

Bristol-Myers Squibb has submitted the latest application on the basis of strong results from a phase III clinical trial, which demonstrated Onglyza’s potential efficacy as a combination therapy.

It has already been ratified by the FDA as a treatment for the improvement of blood sugar control among diabetes patients when used as an adjunct to diet and exercise.

Earlier this month, Bristol-Myers Squibb and its collaborative partner AstraZeneca commenced a phase IV clinical trial of Onglyza as a treatment for type 2 diabetes sufferers with cardiovascular health problems.