1. Pink Sheet

Weighty Issues: GW Obesity Drug Outcomes Project Tests a 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.

It is going to be an important summer for defining the regulatory climate for weight loss drugs.

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...

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