Vivus has responded to the US Food and Drug Administration’s complete response letter regarding its application to market Qnexa as a treatment for obesity and weight loss.
The company has submitted a briefing document to agency addressing the various concerns it had with the New Drug Application, and also announced that it has been grated a meeting with the FDA’s Endocrine and Metabolic Division in the second half of January to discuss its proposed resubmission.
Vivus is seeking to market Qnexa (phentermine/topiramate) controlled-release capsules in the USA as a treatment of obesity, including weight loss and maintenance of weight loss, in patients who are obese or overweight with co-morbidities such as hypertension, type 2 diabetes, dyslipidemia or central adiposity.
But back in October US regulators issued the drugmaker with a series of concerns it had with the drug’s application, including within clinical, labelling, safety and drug scheduling areas.
On the clinical side, the FDA has requested a comprehensive assessment of topiramate's and Qnexa’s teratogenic potential, including a detailed plan and strategy to assess and deal with the potential risks in women of childbearing age. In addition, it has asked for evidence that the elevation in heart rate associated with phentermine/topiramate does not increase the risk for major cardiovascular side effects.
But the company is evidently confident of ultimately securing approval for the drug. “Submission of our briefing document and confirmation of our meeting with the FDA indicate the continued progress Vivus is making in seeking US approval of Qnexa for the treatment of obesity," said Leland Wilson, chief executive officer of Vivus. "We are confident in the data analyses we have compiled in the briefing document, and we look forward to our meeting with the FDA,” he added.