FDA toughens guidelines on diabetes drug approval with closer scrutiny of CV risk
The US Food and Drug Administration has raised the bar to the approval of drugs for type 2 diabetes, recommending that drugmakers provide evidence that their product will not increase the risk of cardiovascular events such as a heart attack.
Drugs for this lucrative disease market have been under greater scrutiny since last year, when a meta-study published in the New England Journal of Medicine linked GlaxoSmithKline's blockbuster diabetes drug Avandia (rosiglitazone) with increased risk of myocardial infarction (Marketletter May 28, 2007).
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