New diabetes drug gets US approval

Published on Thursday 3 August 2000 01:00

US regulators have approved an experimental Bristol-Myers Squibb drug for Type II diabetes that combines two popular medicines that treat the disease by different mechanisms, the company said yesterday.

Bristol-Myers, the No 3 US pharmaceuticals company, said the Food and Drug Administration (FDA) approved Glucovance for use, along with diet and exercise, as initial therapy for the disease, which affects an estimated 15 million Americans.

One of Glucovance’s active ingredients is Glucophage (metformin), the company’s blockbuster Type II diabetes treatment, whose US market exclusivity ends next month. The new drug also contains glyburide, a generic medicine that is a member of the older sulfonylurea class of diabetes treatments.

Glucovance was also approved as second-line therapy for patients with Type II diabetes who are currently taking either Glucophage or a sulfonylurea, but whose blood sugar levels are inadequately controlled.

Glucophage, the company’s top-selling product with second-quarter sales of $485 million, helps the body’s natural stores of insulin do a better job of removing glucose from the bloodstream.

Bristol-Myers has said it hopes Glucovance, as a combined treatment, will enable the company to compete with generic forms of Glucophage expected to hit the market next year.

Glucophage is now approved only for patients who have not been helped by other therapies. Glucovance, by contrast, will have the advantage of being available to those who have never taken other diabetes drugs.