What Belviq Labeling Means For Other Obesity Drug Sponsors
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.
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New Paradigm Would Open More Avenues To Obesity Drug Approval
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.
Vivus Qsymia Launch Includes Strategy To Overcome Medicare Hurdles
Company reports several hundred prescribers have completed online training as part of the Risk Evaluation and Mitigation Strategy for the weight loss drug, which is moving toward a fourth-quarter entry into the marketplace.
Qsymia Sales Reps Recruited For Experience With Metabolic Products
Vivus will benefit from downsizing at other firms, Chief Commercial Officer Mike Miller says. The company will aggressively seek formulary coverage, expects REMS to soothe payer concerns about appropriate use of the obesity product, he notes.