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Weighty Issues: GW Obesity Outcomes Project Tests Model For Patient Input In Drug Development

 
• By Michael McCaughan

A stakeholder project on obesity treatment outcomes will complete its work this summer, setting the stage for FDA to rethink efficacy endpoints for weight loss drug development. The closed-door project is happening in parallel with public advisory committee discussions on pending applications and safety standards. One impact will be to shape more formal patient-centered drug development activities in years to come.

The next few months will be a pivotal time for defining the regulatory climate for weight loss drugs as FDA processes the outcomes of three recent advisory committees – two on potential approvals and one on across-the-board cardiovascular safety standards – but the most important event could be happening behind closed doors.

FDA has two pending applications to decide on – Vivus Inc.’s Qnexa and Arena Pharmaceuticals Inc.’s Lorqess – and, with a 20-2 recommendation in favor of approval by the Endocrinologic & Metabolic Drugs Advisory Committee, most people expect Qnexa to become the first new product for weight loss to clear the agency in more than a decade

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