posted 10/17/02
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: Diabetes In Control Dot Com: Bristol Meyers Squibb.
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