Obesity Therapy Gap Or Regulatory Gap? REMS Not The Answer For Belviq Or GW Group
This article was originally published in RPM Report
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.
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Arena received great news June 27: approval of the weight loss therapy Belviq with a very clean label and no special marketing restrictions. That was what Wall Street expected—except when investors read the summary of the advisory committee review of the drug published by FDA on June 22.
As the fifth year of the REMS era begins, FDA is imposing mandatory programs less frequently than it did even in the first year after the law creating formal risk management plans took effect. But there are some new trends to watch, including the evolution of REMS classes and the emergence of products with REMS-in-waiting.
Weighty Issues: GW Obesity Drug Outcomes Project Tests a Model for Patient Input in Drug Development
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.