Vivus has submitted a New Drug Application (NDA) to the FDA seeking approval of Qnexa, its investigational drug for the treatment of obesity, including weight loss and maintenance of weight loss, in patients with co-morbidities such as hypertension, type 2 diabetes, dyslipidemia or central adiposity.
Reportedly, the NDA submission follows the successful completion of the phase 3 program for Qnexa, including the recently announced results from the two pivotal, year-long phase 3 studies, Equip and Conquer.
In these trials, patients treated with all three doses of Qnexa achieved good percent and categorical weight loss compared to placebo. They also met regulatory requirements for weight loss products as defined in the current FDA Guidance for Developing Products for Weight Management.
In the study, the patients treated with Qnexa also had dose-related improvements in a variety of secondary endpoints, including reductions in cardiovascular and metabolic risk factors.
Previously reported highlights from the two 56-week Equip and Conquer studies comprising more than 3,750 patients include: weight loss of up to 14.7% achieved by patients treated with Qnexa for 56 weeks in the Equip study; improvements in cardiovascular, metabolic and inflammatory risk factors among patients treated with Qnexa; FDA efficacy benchmarks for weight loss agents were exceeded at all three doses of Qnexa tested in the clinical program; completion rates up to 69% were higher than placebo at all three doses of Qnexa, indicating favorable tolerability.
Leland Wilson, CEO of Vivus, said: “This NDA filing is a major milestone for Vivus and the Qnexa program. The weight loss seen in all of the phase 3 trials supports our belief that, if approved, Qnexa could be an effective treatment for patients who are obese or overweight with co-morbidities.”
“The weight loss of up to 14.7% combined with improvements in weight-related medical conditions, such as hypertension, diabetes, and dyslipidemia, demonstrates the importance of treating obesity, which has become a major epidemic in the US and many developed countries. I wish to thank all of the Vivus employees, contractors and advisors who contributed to the program and made this on-time filing possible.”