Weighty Issues: GW Obesity Outcomes Project Tests 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.
You may also be interested in...
The agency is seeking patient community input on process issues related to holding 20 meetings on disease-specific areas over the next five years under PDUFA V. FDA has proposed 39 medical conditions that could be considered for those disease-specific meetings.
Arena’s Belviq is the first obesity drug approval in over a decade, but it won’t be the only one for long. A look at the FDA-approved labeling for lorcaserin offers a preview of how the agency could handle similar issues for Qnexa and, further down the line, Contrave.
The advisory committee on Arena Pharmaceuticals’ lorcaserin continues to bring into focus what FDA and its expert advisers expect in terms of cardiovascular safety assessment for weight-loss drugs, possibly signaling a new consensus and the end of years of confusion.