GlaxoSmithKline Review Supports Avandia, FDA To Review Data

9th Jul 2010 14:39

LONDON (Dow Jones)--GlaxoSmithKline PLC (GSK.LN), a global healthcare group, said Friday its review supports the overall positive benefit-risk profile of Avandia (rosiglitazone maleate) as an important medicine for patients with type 2 diabetes. MAIN FACTS: -The data in GSK's review come from meta-analyses, observational studies and large controlled clinical trials that have become available since July 2007, when the FDA convened advisory committees to review the efficacy and safety of rosiglitazone. -The FDA's Endocrinologic and Metabolic Drugs, and the Drug Safety and Risk Management Advisory Committees will review data at a meeting on July 13 and 14. -Shares at 1337 GMT down 18.5 pence, or 1.6%, at 1123.5 pence. -By Iain Packham, Dow Jones Newswires; 44-20-7842-9269; [email protected] (END) Dow Jones Newswires July 09, 2010 09:39 ET (13:39 GMT)