US FDA advisory panels vote to keep GlaxoSmithKline's diabetes drug Avandia on the market; GSK updates on legal issues

To the delight of GlaxoSmithKline, but no doubt to the surprise - even dismay - of others, US Food and Drug Administration advisors have voted to keep the UK drug giant's type 2 diabetes drug Avandia (rosiglitazone) on the market, despite suggested cardiovascular side effects, albeit with added warnings. The news saw GSK's shares edge 1.1% higher to £11.95 in early trading this morning.

The two-day hearings of a joint meeting of the FDA's Endocrinologic and Metabolic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee - which included an unusually large number of 33 panelists (The Pharma Letter July 14), ended yesterday with a vote by 20 of the total experts backing retaining Avandia with various options on additional warnings. Seven panelists voted for additional warnings and three for marketing with the current label. Only 12 of the experts voted to recommend that the FDA should withdraw the drug altogether, with one abstention.

TIDE trial should continue