FDAnews
www.fdanews.com/articles/84428-gsk-launches-avandaryl

GSK LAUNCHES AVANDARYL

February 8, 2006

GlaxoSmithKline (GSK) has launched Avandaryl, a new fixed-dose combination product for Type 2 diabetes.

Approved in December 2005, Avandaryl (rosiglitazone maleate and glimepiride) is a combination of GSK's Avandia and Amaryl. Over 18 million Americans have Type 2 diabetes, the most common form of diabetes, said GSK.

An estimated 64 percent of Type 2 diabetes patients are not well controlled on their current therapy, said Barry Goldstein, director of the Division of Endocrinology, Diabetes and Metabolic Diseases at the Jefferson Medical College of Thomas Jefferson University in Philadelphia.

"Avandaryl, a combination of rosiglitazone and a sulfonylurea, provides two different, yet complementary, mechanisms of action to treat diabetes by improving blood sugar control in patients with Type 2 diabetes," he said. "The patient's treatment regimen combines these two medicines into one convenient tablet."

The combination product 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.