FDA advisory panel votes to keep GSK's Avandia on US market but with warnings

UK pharmaceutical giant GlaxoSmithKline received a welcome reprieve for its recently-battered type 2 diabetes drug Avandia (rosiglitazone), when a joint meeting of the US Food and Drug Administration's Endocrinology and Metabolic Drugs and the Drug Safety and Risk Management Advisory Committees voted 22 to one in favor of keeping the drug on the US market.

The non-binding vote came after the UK stock market closed on July 30, but GSK's shares moved up 3.2% to L12.53 the next day, recovering some recent lost ground as the controversy over its drug rolled on and prescriptions declined (Marketletters passim). The stock has lost about 14% of its value since May 21, when the safety of Avandia (which had $3.0 billion sales last year) was raised by a New England Journal of Medicine article.

The decision came despite some dissensions and will result in the requirement for increased safety warnings. The EMDDS panel voted on the two questions posed by the FDA, namely: