The FDA has approved the weight-loss drug Qsymia, formerly Qnexa, (Vivus, Mountain View, CA), which now joins lorcaserin (Belviq, Arena Pharmaceuticals, San Diego, CA) as the first anti-obesity medications to enter the US market since 1999. Vivus reported the agency's decision today.
Qsymia, a controlled-release preparation of the drugs phentermineand topiramate in one capsule, is now indicated for weight loss and maintenance of weight loss for people who are obese, or those who are overweight and have weight-related conditions such as hypertension, type 2 diabetes, or dyslipidemia.
Vivus is also exploring Qsymia for type 2 diabetes and obstructive sleep apnea in phase-2 studies.
In February, an FDA advisory panel voted overwhelmingly in favor of the drug's approval for obesity, despite some concerns about possible adverse effects such as raised blood pressure and birth defects, as reported byheartwire .
The agency then took the step--not unusual in such cases--of giving the company a three-month extension on the period during which it could review its application, which ended today. That allowed the FDA to consider the Risk Evaluation and Mitigation Strategy (REMS) for Qsymia that Vivus had submitted on April 4.
Many on the advisory panel had stated that their vote favoring Qsymia--it was ultimately 20 to 2--assumed that the company would in fact submit and implement a REMS, parts of which Vivus described at the hearing. That regulators granted an extension to facilitate that process was as good a sign as any that it was leaning toward a positive decision.
Both the FDA and its advisory committee had decided against approval of Qsymia on its first round of consideration in October, 2010, pending a more comprehensive assessment of its safety. Lorcaserin had followed a similar path in the premarket process, having been denied approval the same week for similar reasons; the agency approved lorcaserin just a few weeks ago.
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