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Published on 7/11/2006 in the Prospect News Biotech Daily.

GlaxoSmithKline's Avandamet approved by FDA for treatment of type 2 diabetes

By Lisa Kerner

Charlotte, N.C., July 11 - The Food and Drug Administration approved GlaxoSmithKline's Avandamet (rosiglitazone maleate and metformin HCl) for use as initial treatment of type 2 diabetes in addition to diet and exercise.

Avandamet was previously approved as a second-line therapy for patients who were uncontrolled on metformin monotherapy.

"The combination of rosiglitazone and metformin provides two complementary mechanisms of action," said Barry Goldstein, the director, Division of Endocrinology, Diabetes and Metabolic Diseases, Jefferson Medical College of Thomas Jefferson University, in a news release.

"Rosiglitazone targets insulin resistance, an underlying cause of type 2 diabetes, whereas metformin primarily works to reduce the amount of blood sugar (or glucose) produced by the liver."

A clinical trial comparing Avandamet to both rosiglitazone alone and metformin alone demonstrated that patients taking Avandamet achieved significantly lower blood sugar levels than with either monotherapy, officials said.

GlaxoSmithKline is a research-based pharmaceutical and health care company based in Philadelphia.


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