Issue 126 Item 6 FDA Approves New Indication for Glucovance

Glucovance OK’ed to use with Thiazolidediones, which makes it a triple therapy. >Drugmaker Bristol-Myers Squibb Company said on Friday that it received a supplementary approval from the US Food and Drug Administration (FDA), allowing the use of its type 2 diabetic therapy Glucovance (glyburide and metformin HCl) along with thiazolidinediones (TZDs), such as Avandia (rosiglitazone) and Actos (pioglitazone).

The FDA first approved Glucovance in August 2000 as an adjunct to diet and exercise.

Bristol-Myers said the new indication is expected to provide physicians with yet another therapy option by allowing for the addition of a TZD when patients require additional blood sugar control.

The new indication was based on results from a 24-week clinical study, the company said, in which 42% of patients receiving both Glucovance and Avandia achieved a hemoglobin A1c level of <7%, the treatment goal presently recommended by the American Diabetes Association (ADA).

Bristol-Myers added that more than 8 million patients have been prescribed Glucovance over the last 2 years alone, establishing the drug as one of the nation’s leading type 2 diabetes therapies.

Glucovance is the next generation formulation of Bristol-Myers’ initial type 2 diabetes therapy Glucophage (metformin), which lost its patent protection in January of this year. Source: Bristol Meyers Squibb