The FDA Ponders Tougher Hurdles For New Diabetes Drugs

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The Food and Drug Administration is considering a requirement that before receiving agency approval, new diabetes treatment drugs must not only lower blood sugar levels, but also demonstrate a positive effect on heart disease and lifespan.

Such a requirement would mark a dramatic shift away from traditional benchmarks of diabetes drug performance, which are called “surrogate endpoints” in the drug approval process. Currently, the surrogate endpoints for diabetes treatment drugs center on their ability to blood sugar level controls—a fairly easy goal to track.

But in light of the recent halt of the ACCORD study when it was found that very tight control of blood sugars among type 2s seemed to increase risk of fatal heart attacks, the FDA is concerned that lowering blood sugars is not enough.

Because cardiovascular problems are the number-one killer of people with diabetes, the agency may decide to add new surrogate endpoints, namely a reduced risk of cardiovascular disease and a lengthened lifespan.

The FDA’s discussion was in part inspired by a recent study that strongly suggested that although users of GlaxoSmithKline’s Avandia enjoyed lower blood sugar levels, their lifespan did not increase because of a greater risk for heart attack. (Glaxo says that its own studies showed no increased risk of heart disease among Avandia users.)

Drug manufacturers worry that if the FDA does add these additional conditions to the drug approval process, the new end points will be much harder to track and prove—a circumstance that could considerably lengthen the time and cost it takes to bring a new diabetes drug to market.

An agency panel began discussing the issue on July 1, 2008. It has not said when it will announce its preliminary conclusions.

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