PRESS RELEASE
Sept. 15, 2011, 6:45 a.m. EDT
VIVUS Provides Regulatory Update on QNEXA
Agreement Reached with FDA to Re-Submit QNEXA NDA Prior to Completion of FORTRESS
MOUNTAIN VIEW, Calif., Sept. 15, 2011 /PRNewswire via COMTEX/ -- VIVUS, Inc. VVUS +9.62% today announced that following a recent teleconference it has reached agreement with officials of the Endocrine and Metabolic Division of the Food and Drug Administration on a plan that allows for an early resubmission of the QNEXA New Drug Application for the treatment of obesity. The resubmission plan allows VIVUS to seek approval for an initial indication that includes obese men and women of non-child bearing potential. Based on this agreement, VIVUS intends to resubmit the QNEXA NDA by the end of October 2011, prior to completion of the FORTRESS study. Top-line results from FORTRESS are expected in December 2011, with validation of FORTRESS expected in the third quarter of 2012. The FDA also stated that an Advisory Committee meeting for QNEXA will be held in the first quarter of 2012.
"Recent epidemiology study results, which show that topiramate is not a major teratogen, were an important consideration in our plan to resubmit the QNEXA NDA ahead of the FORTRESS results. The planned October resubmission will also allow for an early 2012 Advisory Committee meeting and a second quarter 2012 PDUFA date," commented Peter Y. Tam, president of VIVUS. "In this initial indication, we plan to include a contraindication for women of childbearing potential. We believe this is a sound approach that, if approved, will potentially allow early commercialization in a higher-risk population with a significant unmet medical need. The FORTRESS study remains important in our plan to more precisely define the teratogenic potential of topiramate and may enable us to expand the indication to include obese women of child-bearing potential. If the FORTRESS results are favorable, we expect to file for the full indication in late 2012."
According to the CDC, over 108 million adult Americans are estimated to have a BMI >30 (obese) or BMI >27 (overweight) with at least one weight-related health risk, such as diabetes, hypertension or dyslipidemia. Of these, over three-quarters, or an estimated 80 million adults, are men and women of non-childbearing potential who are at an increased risk of developing obesity-related cardiovascular and metabolic diseases.
"Topiramate teratogencity data published and presented since our last meeting with the FDA in April 2011 includes two case-control studies utilizing the CDC's National Birth Defects Prevention Study and the Slone Epidemiology Birth Defect Study presented at the 27th International Conference on Pharmacoepidemiology and Therapeutic Risk Management in Chicago; and the Wolters Kluwer Study presented at International Epilepsy Congress in Rome. In addition, a birth defect study from Denmark on Newer Generation Antiepileptic Drugs including topiramate was published in JAMA. In all of these studies, the authors concluded that topiramate was not a major teratogen," commented Wesley Day, vice-president clinical development. "The conclusions reached in all of these studies were instrumental in the development of the QNEXA NDA resubmission plan."
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