FDA Updates Label for Avandia to Include Clinical Findings Demonstrating Sustained Glycemic Control for Up to Five Years

GlaxoSmithKline 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.

The details can be read here.