FDA Approves Vivus’ Obesity Drug, Recommends Against Use In High-Risk Heart Patients
This article was originally published in The Pink Sheet Daily
A Risk Evaluation and Mitigation Strategy for Qsymia includes prescriber education about the risk of birth defects and limits dispensing to specially certified pharmacies
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Fixed-dose combination of phentermine and topiramate is FDA-approved for chronic, long-term use, but the average duration in the real world is only about 2.1 months, which is reassuring for Qsymia’s cardiovascular safety, according to a new retrospective claims study.
Filing for a drug with questionable risk-benefit profile was saved by a trial protocol redesign, strict safety labeling for a narrow indication, a REMS, patient mobilization and plenty of postmarketing studies. Trial period echoes FDA’s approach with a similar sector of lifestyle drug: obesity.
Sales of the weight-loss drug haven’t been brisk, but Vivus can fortify its balance sheet with up to $110 million in debt. Analysts say it could raise more soon, provided it gains a regulatory victory.