Thursday, July 3, 2008

Panel urges stricter diabetes testing

Yesterday, a panel of FDA advisers voted 14-2 that the FDA should require drug makers to show that experimental diabetes drugs don’t increase cardiovascular risks.

If the FDA takes the panel’s advice, it could be more expensive for drug makers because it takes a much bigger, longer trial to prove heart safety than to prove blood-sugar control.

AstraZeneca and Bristol-Myers Squibb could be on the short list of those affected by any changes; the companies are planning to submit their diabetes drug saxagliptin for FDA approval soon.

Merck could benefit from the changes because its diabetes drug Januvia has already been approved, and would compete with saxagliptin, which is in the same class.

GlaxoSmithKline’s Avandia found itself at the center of a storm last year after an analysis suggested the drug raised the risk of heart attacks. The company claims the drug is safe, and it remains on the market, at least for now. Ironically, that debate may well have led to the FDA being pressured to reconsider how it approves diabetes medications.



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