Panel Continues To Push For Obesity CV Guidance As It Backs Contrave Approval
FDA signaled during an advisory committee on Orexigen's weight-loss drug Contrave that it could be ready to revise its obesity drug draft guidance, particularly with regard to cardiovascular goals, but stressed that for now, the drugs under review are to be judged by standards articulated in the draft document.
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Assessments of obesity drugs should look at their effects in patients grouped by health status and FDA should expand the universe of secondary endpoints available to assess benefits, a group of stakeholders says.
Group convened by George Washington University School of Public Health and Health Services recommends a “patient-centered” approach to reviewing obesity drugs that includes assessing the therapies for their risks and benefits for obese individuals who are healthy, have risk factors for co-morbidities or impairments to daily feeling or functioning, or are already sick.
With a July 17 user fee date, Vivus’ obesity drug Qnexa could beat Arena Pharmaceuticals’ Belviq to the marketplace as lorcaserin awaits controlled substance scheduling by the Drug Enforcement Agency.