- Earlier today, Vivus announced that data from SEQUEL was published in The American Journal of Clinical Nutrition.
At IDF, Vivus announced that two-year data from the company’s SEQUEL trial were published in The American Journal of Clinical Nutrition. While topline data from the trial were first reported in September 2010 (see our September 21, 2010 Closer Look at http://www.closeconcerns.com/knowledgebase/r/9d5086f3), the newly published data provides additional detail (see below). With the publication of SEQUEL results in AJCN, and publication of EQUIP results in Obesity and CONQUER results in The Lancet, awareness of the benefits of Qnexa is on the rise; we assume these publications, especially the two-year SEQUEL data, will be very useful in its upcoming FDA Advisory Committee meeting. Indeed, this is big win for Vivus since one of the issues in the complete response letter from the FDA had been the need for longer-term data1; having the full SEQUEL results scientifically vetted and in the public domain should be quite positive for Vivus, given the results and timing.
As the publication notes, in SEQUEL, patients receiving mid-dose Qnexa and patients receiving full-dose Qnexa had an average weight loss of 9.3% and 10.5%, respectively, over the course of two years, compared to 1.8% weight loss with placebo. In addition, the publication highlights the improvements in cardiovascular and metabolic risk factors with Qnexa treatment, as well as a decrease in the use of concomitant medications. These long-term results are certainly better than anything available to patients now; from our view, the most valuable part of the drug may well be the side effect profile, since to date, side effects associated with obesity compounds have been so challenging. While the most common adverse events with Qnexa were upper respiratory infection, constipation, tingling, sinus infection, dry mouth, and runny nose, they affect a considerably lower percentage of patients than have other obesity compounds and are in our view more benign.
As a reminder, Vivus resubmitted Qnexa to the FDA in October 2011, excluding women of childbearing potential from its proposed indication. The agency will hold a second advisory committee meeting in 1Q12 to discuss the benefits and risks of Qnexa, and will decide whether to approve the drug by April 17, 2012. We expect the Ad Comm meeting to focus on teratogenicity, heart rate, and longer-term data. Meanwhile regarding its European submission, Vivus expects to respond to the European Medicines Agency’s 120-day list of questions in 4Q11.
1 Despite the fact that obesity guidance from FDA doesn’t ask for two-year data, some of the Ad Comm members expressed disappointment that this was not available. We remain somewhat frustrated that the guidance from FDA isn’t in line with what Ad Comm members request and hope that this inconsistency becomes a greater focus for FDA.
--by Vincent Wu and Kelly Close