FDA Pressed At Meridia Committee Review To Finalize Obesity Drug Guidance
FDA is facing strong pressure from its own advisory committee members to finalize development standards for weight-loss drugs.
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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.
Endocrinologic and Metabolic Drugs Advisory Committee also will weigh in on a teratogenicity risk management strategy for Vivus’ weight-loss drug during a Feb. 22 meeting.
Orexigen halts Contrave development for U.S., but the firm will appeal the division's "unprecedented" trial request through FDA's dispute resolution process.