FDA Asks VIVUS (VVUS) to Adjust Contraindicting Qnexa Label for Pregnant Women
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VIVUS, Inc. (Nasdaq: VVUS) today announced that following recent discussions with Food and Drug Administration (FDA) officials, the company has been asked to remove the Qnexa contraindication for women of childbearing potential contained in the proposed label. Qnexa would remain contraindicated for women who are pregnant. A contraindication typically indicates that a drug should not be used because the risk of use clearly outweighs any possible therapeutic benefit.
Included with the resubmission of the Qnexa New Drug Application (NDA) was a proposed Risk Evaluation and Mitigation Strategy, or REMS. The company is currently revising its proposed REMS based on this change in the contraindication and plans to discuss the details of the Qnexa REMS during the upcoming Endocrinologic and Metabolic Drugs Advisory Committee.
In September 2011, the company announced that it reached agreement with the FDA on a plan that allowed for an early resubmission of the Qnexa NDA. The resubmission plan allowed VIVUS to seek approval for an initial indication that included obese men and women of non-childbearing potential which contained a contraindication for women of childbearing potential. Based on this agreement, VIVUS resubmitted the Qnexa NDA in October 2011. The FDA accepted the NDA for review on November 3, 2011.
The Endocrinologic and Metabolic Drugs Advisory Committee of the FDA is scheduled to review the Qnexa NDA on February 22, 2012. The target date for the FDA to complete its review of the Qnexa NDA is April 17, 2012.
Included with the resubmission of the Qnexa New Drug Application (NDA) was a proposed Risk Evaluation and Mitigation Strategy, or REMS. The company is currently revising its proposed REMS based on this change in the contraindication and plans to discuss the details of the Qnexa REMS during the upcoming Endocrinologic and Metabolic Drugs Advisory Committee.
In September 2011, the company announced that it reached agreement with the FDA on a plan that allowed for an early resubmission of the Qnexa NDA. The resubmission plan allowed VIVUS to seek approval for an initial indication that included obese men and women of non-childbearing potential which contained a contraindication for women of childbearing potential. Based on this agreement, VIVUS resubmitted the Qnexa NDA in October 2011. The FDA accepted the NDA for review on November 3, 2011.
The Endocrinologic and Metabolic Drugs Advisory Committee of the FDA is scheduled to review the Qnexa NDA on February 22, 2012. The target date for the FDA to complete its review of the Qnexa NDA is April 17, 2012.
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