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Published on 2/1/2006 in the Prospect News Biotech Daily.

GlaxoSmithKline announces approval, availability of Avandaryl for diabetes

By Lisa Kerner

Erie, Pa., Feb. 1 - GlaxoSmithKline announces the availability of Avandaryl (rosiglitazone maleate and glimepiride), a new fixed-dose combination product for type 2 diabetes recently approved by the Food and Drug Administration.

Avandaryl is the only tablet to combine a thiazolidinedione (TZD), rosiglitazone maleate (separately marketed as Avandia), with a sulfonylurea, glimepiride (separately marketed as Amaryl) to help improve blood sugar control, according to a company news release.

Rosiglitazone directly targets insulin resistance and helps the body respond to its own natural insulin. Sulfonylureas help the body release more of its natural insulin.

As an adjunct to diet and exercise, Avandaryl is indicated to improve blood sugar control in patients with type 2 diabetes who are already treated with a combination of rosiglitazone and sulfonylurea or who are not adequately controlled on a sulfonylurea alone, or for those patients who have initially responded to rosiglitazone alone and require additional blood sugar control, the company said.

Avandaryl is available in three tablet strengths of rosiglitazone/glimepiride, respectively: 4 mg/1 mg, 4 mg/2 mg and 4 mg/4 mg.

"GlaxoSmithKline is committed to researching new options for the treatment of type 2 diabetes, a disease that impacts a significant and growing number of individuals and their families," said Brian A. Lortie, vice president, anti-infective, metabolic and endocrine marketing. "Avandaryl, the newest addition to [GlaxoSmithKline's] diabetes franchise, offers an effective and convenient treatment option to help patients manage type 2 diabetes."

It is estimated that more than 18 million Americans have type 2 diabetes. Diabetes-related complications affect the eyes, kidneys, nerves and heart.

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


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