Bristol-Myers Squibb receives FDA approval of Glyburide/ Metformin HCL combination tablets for type 2 diabetes

With the uncertainty regarding glitazone treatments for type 2 diabetes, particularly after the withdrawal of Warner-Lambert's Rezulin (see related article, companies involved in diabetes drugs must look for ways to extend the useful market life of other important diabetes drugs.

On August 2, the U.S. Food and Drug Administration approved Glucovance, Bristol-Myers Squibb Co.'s (Princeton, NJ) combination Glyburide and Metformin HCl Tablet product as initial drug therapy for type 2 diabetes. The drug was also approved as second-line therapy for patients with type 2 diabetes who are currently taking either or a sulfonylurea and a regimen of diet and exercise, but whose blood sugar levels are inadequately controlled. Glucovance combines glyburide and Glucophage—the two most widely prescribed oral antidiabetic agents—in a single pill.

"Glucovance represents a new approach to managing type 2 diabetes," said Richard J. Lane, president, Worldwide Medicines Group, Bristol-Myers Squibb. "It is our hope that the introduction of this novel agent could change the treatment paradigm for the more than 15 million patients in the U.S. with this condition."

Glucovance (Glyburide and Metformin HCl Tablets) will be available in three dosing strengths, including 1.25 mg/250 mg (glyburide/metformin) tablets, 2.5 mg/500 mg tablets, and 5 mg/500 mg.

For more information, contact Bonnie Jacobs of Bristol-Myers Squibb at 609-897-4868.

Edited by Angelo DePalma
Managing Editor, Drug Discovery Online