U.S. Food and Drug Administration (FDA) have asked the company to clear the warnings on Qnexa i.e. the obesity drug by Vivus, Mountain View, CA-based biotechnology firm, for women of childbearing age in its resubmitted New Drug Application (NDA) as reported by the company today.“Based on our discussions with the FDA, we will modify the contraindication and develop an appropriate REMS with FDA’s guidance. It is important for patients seeking treatment to understand and be reminded of the potential risks associated with Qnexa. In addition to other elements, the proposed REMS program will focus on the education of patients and healthcare providers through frequent communications that will outline the safety aspects and appropriate use of Qnexa,” commented Peter Tam, president of VIVUS, Inc. “The company’s disclosure of this regulatory update should not be interpreted to mean that the potential for FDA approval of Qnexa has improved or that, if approved, that the final Qnexa label would not include contraindications or warnings for specific populations, including women of childbearing potential.”
Company can be the first in getting the weight drug approval in more than a decade. According to the company, the Endocrinologic and Metabolic Drugs Advisory Committee of the FDA would complete the Qnexa NDA review by February, 2012 and complete the review process by April, 2012.
Shares of Vivus increased by more than 14% this morning after the news.