FDA Updates Label for AVANDIA(R) to Include Clinical Findings Demonstrating Sustained Glycemic Control for Up to ...( Data Provides Further Information...),Health

Data Provides Further Information on AVANDIA as a Safe and Effective

Treatment Option for Appropriate Type 2 Diabetes Patients

PHILADELPHIA, July 14 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK) announces today that the U.S. Food and Drug Administration (FDA) updated the prescribing information for AVANDIA(R) (rosiglitazone maleate) to include clinical findings from A Diabetes Outcome Progression Trial (ADOPT), a 4- to- 6 year head-to-head study of AVANDIA versus metformin and glyburide monotherapy in recently diagnosed type 2 diabetes patients. The percentage of patients with inadequate glucose control at five years was 34 percent with glyburide, 21 percent with metformin and only 15 percent with AVANDIA. The difference between AVANDIA and the comparators was statistically significant.

"GSK is pleased that the FDA has approved inclusion of the results from ADOPT, an important clinical trial that provides substantial long-term efficacy and safety data on AVANDIA compared to metformin and sulfonylurea," said Alexander R. Cobitz, MD, PhD, Senior Director, Metabolism, Clinical Development and Medical Affairs, GlaxoSmithKline. "As demonstrated in this study, patients treated with AVANDIA achieved greater sustained glycemic control. Better glycemic control has been proven to reduce risks of serious complications associated with type 2 diabetes including blindness, loss of limbs and kidney failure."

Study Design

ADOPT was a large, international, multi-center, randomized, double-blind, parallel-group study involving 4,351 people, aged 30-75 years who were recently diagnosed with type 2 diabetes (less than or equal to 3 years) from more than 400 sites throughout North America and Europe. ADOPT, conducted over a period of 4 to 6 years, assessed the cumulative incidence of monotherapy failure at five years with AVANDIA, metformin, glyburide, as defined by consecutive fasting plasma glucose (FPG) >180 mg/dL.

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