FDA Accept Glucovance

Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration (FDA) has approved Glucovance™ (glyburide and metformin HCl tablets) for use, along with diet and exercise, as initial drug therapy for people with 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. These agents work together to improve blood sugar in patients with type 2 diabetes.

"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 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.

Glucovance has been proven safe and effective in clinical trials. In rare cases, Glucovance (or glucophage) may cause lactic acidosis, which can be fatal in up to half of the cases. Lactic acidosis occurs mainly in people whose kidneys are not functioning properly. Patients should not take these drugs if they have kidney problems, if they are 80 or older (unless they have their kidneys tested first), if they are taking medication for heart failure, if they have a history of liver disease or if they drink alcohol excessively. The most common side effects of Glucovance are normally minor ones such as diarrhea, nausea, and upset stomach. Less frequently, symptoms of hypoglycemia (low blood sugar) such as lightheadedness, dizziness, shakiness, or hunger may occur.