1. Pink Sheet

Obesity Therapy Gap Or Regulatory Gap? REMS Not The Answer For Belviq Or GW Group

 
• By Michael McCaughan

A common theme in FDA’s review of three different weight loss drugs has been discussion of whether a Risk Evaluation & Mitigation Strategy program can help assure appropriate use of the therapies. FDA clearly thinks the answer is “no.” But that doesn’t end the discussion of what tools can be used to help curb off-label use.

When it comes to finding a path to approval for obesity therapies in the U.S., the Food & Drug Administration has concluded that a Risk Evaluation & Mitigation Strategy is not the answer after all. FDA made that very clear this summer in two very different contexts that involved direct discussion of whether to use the REMS authority in the weight loss class.

The first and most direct decision came when the Food & Drug Administration approved Arena Pharmaceuticals Inc./Eisai Co. Ltd.’s Belviq (lorcaserin) for treatment of obesity on June 27....

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