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SILVER SPRING, Md. — As a Food and Drug Administration advisory committee convenes to decide whether or not to approve a new drug for treating obesity, two nonprofit groups centered on the epidemic said more means of addressing it are needed.
The Obesity Society and the Obesity Action Coalition said Monday that they were urging the FDA Endocrine and Metabolic Drugs Advisory Committee to consider the need for more measures against obesity as the committee reviewed an application for Orexigen Therapeutics’ anti-obesity drug Contrave (naltrexone and bupropion), with the review scheduled for Tuesday.
Obesity affects some 93 million Americans, but the FDA has turned down approval applications for two obesity drugs, including Vivus’ Qnexa (phentermine and topiramate) and Arena Pharmaceuticals’ Lorquess (lorcaserin), while requesting that Abbott’s weight-loss drug Meridia (sibutramine) be removed from the market due to safety concerns.
“We are deeply concerned about the effect that the FDA’s recent decisions will have for ongoing and future research into desperately needed new obesity treatments,” Obesity Society president Jennifer Lovejoy stated. “As the FDA’s advisers consider the application before them, we hope that the agency will assure a balanced process, taking into account the urgent medical need.”