FDA approves new indication for Glucovance oral antidiabetic
NEW YORK, N.Y., Oct. 11, 2002 --Bristol-Myers Squibb announced that the FDA has approved a new indication for Glucovance (glyburide and metformin HCl tablets), a widely-prescribed oral antidiabetic agent.
The FDA has approved Glucovance, as an adjunct to diet and exercise, for use in combination with another class of antidiabetic agents known as thiazolidinediones (TZDs), when adequate glycemic control is not achieved with Glucovance and diet and exercise.
The new indication provides physicians with yet another Glucovance therapy option by offering the flexibility of adding a TZD when patients require additional blood sugar control.
"Glucovance works by treating the major problems associated with type 2 diabetes -- the inability to release sufficient insulin and the inability to use it effectively," said George Dailey, M.D., head of the Division of Diabetes and Endocrinology, Scripps Clinic. "This new indication for Glucovance is an important treatment option in the struggle to control type 2 diabetes."
The new indication for Glucovance is based on results from a 24-week clinical study, which evaluated the effects of adding rosiglitazone (a member of the thiazolidinedione class of agents) or placebo to the therapy regimen of patients with type 2 diabetes not adequately controlled on current oral antidiabetic therapy (either monotherapy or combination therapy) who were first switched to Glucovance.
In the study, 42 percent of patients on Glucovance plus rosiglitazone achieved an A1C level of <7 percent, which is the treatment goal recommended by the American Diabetes Association (ADA).
Glucovance is a product that combines glyburide and Glucophage® (metformin HCl tablets) -- two widely prescribed oral antidiabetic agents -- in a single pill. In clinical studies, Glucovance showed significantly greater reductions in glucose levels than glyburide or metformin. Glucovance was originally approved by the FDA in August 2000 and more than 8 million prescriptions have been written for the product during the past two years.
Glucovance is not for everyone. In rare cases, Glucovance may cause lactic acidosis (build-up of lactic acid in the blood), which is serious and can be fatal in half the cases. This occurs mainly in people whose kidneys are not functioning properly. Patients should tell their doctor about their alcohol use because it can increase their risk. Patients should not take Glucovance if they: have kidney problems, are 80 or older (unless their kidneys have been tested), are taking medication for heart failure, are seriously dehydrated, have a serious infection, or if they have or have had liver disease.
Full prescribing information for Glucovance (glyburide and metformin HCI tablets) and Glucophage (metformin hydrochloride tablets) is available at www.bms.com.
Source: Bristol-Myers Squibb Company
Posted: October 2002