FDA Approves Glucophage XR for Type 2 Diabetes
Approval provides patients with benefits of number one prescribed diabetes pill in a convenient once-daily formulation
Darmstadt/Germany, October 17, 2000 - Merck KGaA today announced that Bristol-Myers Squibb Company received the U.S. food and Drug Administration (FDA) approval of Glucophage® XR (metformin HCl extended release tablets) for use as initial drug therapy for patients with type 2 diabetes whose hyperglycemia cannot be controlled with diet and physical exercise alone. Glucophage® is a registered trademark of Lipha S.A., the Ethicals business of Merck KGaA in France, and is licensed to Bristol Myers Squibb in the United States.
Glucophage XR is a once-daily dosage form of Glucophage (metformin hydrochloride tablets), the number one prescribed type 2 diabetes pill in the United States. In clinical trials with more than 1,200 patients, Glucophage XR was shown to be comparable to Glucophage in lowering patients' blood sugar levels. In addition to initial therapy, the FDA also approved Glucophage XR for use by patients who require combination therapy with sulfonylureas or insulin.
The approval of Glucophage XR complements the comprehensive range of approved type 2 diabetes treatments offered by Merck KGaA and its US licensee, Bristol-Myers Squibb. In August 2000, Bristol Myers Squibb received FDA approval of GlucovanceTM (Glyburide and Metformin HCl Tablets). This unique drug represents a new approach to managing type 2 diabetes and works by combining 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.
Earlier this month, Merck KGaA and Novartis AG announced that the Swiss regulatory authorities have granted approval for Starlix® (nateglinide) for the treatment of type 2 diabetes. Based on a co-promotion/co-marketing agreement between Merck KGaA and Novartis that includes Europe and certain African, Southeast Asian and Latin American countries, both companies will introduce Starlix in Switzerland by the end of this year.
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