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Update on Glaxo's Avandia

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GlaxoSmithKline’s (GSK - Free Report) Avandia is available for type II diabetes. Avandia came under the FDA scanner in 2007 after an article in the New England Journal of Medicine (NEJM) linked the use of Avandia (rosiglitazone) with increased risk of cardiovascular events. Following the report Glaxo revised the U.S. label on Avandia.

In 2010, the European Medicines Agency (EMA) banned Avandia, while the FDA severely restricted the use of the drug. Annual sales of Avandia have fallen drastically to £6 million (in 2012) from £1.6 billion in 2006.

In Nov 2013, Glaxo announced that the U.S. Food and Drug Administration (FDA) has eased the restrictions on Avandia use. The FDA has suggested label modification about cardiovascular safety apart from certain changes to the Risk Evaluation and Mitigation Strategy (REMS) program. The FDA has waived the post market study requirement.

In Jun 2013, the joint advisory committee (comprising the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee) to the FDA voted in favor of easing safety restrictions related to Avandia.

 Of the 26-member panel, 13 voted in favor of modifying and 7 in favor of removing the Avandia REMS program. However, 5 members were in favor of continuing the REMS and 1 recommended removal of Avandia from the U.S. market.

We remind investors that the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial did not show an elevated risk of heart attack or death in patients being treated with Avandia versus standard diabetes therapies.
We note that Avandia patents have already expired in the U.S. We believe that with major players like Sanofi (SNY - Free Report) and Novo Nordisk (NVO - Free Report) already in the diabetes market, Avandia sales are not likely to increase significantly.

Glaxo, a large cap pharma company, carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the large cap pharma space include Bayer (BAYRY - Free Report) , which carries a Zacks Rank #2 (Buy).

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