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The Race for Avandia's Share: May the Safest Product Win

This article was originally published in RPM Report

Executive Summary

The safety problems with GlaxoSmithKline's Avandia have left a large chunk of the diabetes market open to competing products, and the outcome of an FDA advisory committee meeting could leave even more up for grabs. Who will be the big winner in the race for market share?

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Don't Cry Too Hard for Avandia

GSK suffered a major commercial loss after news of Avandia's cardiovascular safety exploded onto the market in 2007. But there is a sliver of a silver lining for GSK: FDA's post-Avandia safety rules may make it tougher for new competing products to reach the market.

Don't Cry Too Hard for Avandia

GSK suffered a major commercial loss after news of Avandia's cardiovascular safety exploded onto the market in 2007. But there is a sliver of a silver lining for GSK: FDA's post-Avandia safety rules may make it tougher for new competing products to reach the market.

The Avandia Penumbra: Remapping Diabetes Drug Development

The implosion of Avandia has raised several critical issues for diabetes drug developers, including whether companies can still rely on glycemic control as the primary endpoint for approval and the extent to which late-stage comparative trials conducted versus Avandia are still useful. The decisions FDA makes in the wake of Avandia will also be important milestones affecting other therapeutic categories, as they will reflect how the agency is assessing and monitoring drug safety generally.

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