FDA Panel: Glaxo's Avandia Can Stay on the Market

GlaxoSmithKline ADRs gained 5.5% to $52.15 in AH trading Monday after an FDA advisory panel refrained from recommending that its diabetes drug Avandia (rosiglitazone) be pulled from the market despite increased risk of heart attack. Avandia was Glaxo's second-biggest-selling drug in 2006 with global sales of $3.38 billion. Several panel members favor a stiffer warning label for Avandia rather than its full withdrawal. One possible beneficiary of a black-box or other new warning on Avandia could be Takeda Pharmaceuticals, which produces Actos, Avandia's only direct rival. Actos has not been tied to increased heart attack risk. The FDA panel showed signs of sharp disagreement before its decision, with two officials, David Graham and Gerald Dal Pan, arguing that Avandia's risks outweigh its benefits. "If rosiglitazone increases the cardiovascular risks, a wrong decision will cost thousands of lives," Graham said. The panel ultimately voted 20-3 that the drug increased ischemic (heart attack) risk but voted 22-1 to keep it on the market. Glaxo has argued consistently that Avandia does not increase heart attack risk. "The number of myocardial infarctions is small, the data are inconsistent and there is no overall evidence rosiglitazone is different from any other oral antidiabetes agents," said Glaxo's chief medical officer Dr. Ronald Krall.

Sources: Wall Street Journal, AP, Dow Jones, Bloomberg
Commentary: GlaxoSmithKline Wins The Latest Round on Avandia • GlaxoSmithKline Defends Avandia Against Charges of Cardiovascular Risks • FDA Wants Black Box Warning on Glaxo's Avandia and Lilly's Actos
Stocks/ETFs to watch: GSK. Competitors: TKPHF.PK, MRK, AMLN. ETFs: EKH, OTP
Earnings call transcripts: GlaxoSmithKline Q2 2007
Related: WSJ health blogger Jacob Goldstein discusses latest Avandia news

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