The Endocrinologic and Metabolic Drugs Advisory Committee of the US Food and Drug Administration (FDA) is tentatively scheduled to review the New Drug Application (NDA) for VIVUS’ [removed]Qnexa[/removed] for the treatment of obesity on July 15, 2010.
VIVUS submitted its NDA on December 28, 2009, seeking approval to market Qnexa in the United States; on March 1, 2010, the FDA accepted the NDA filing for review. The target date for the FDA to complete its review of the Qnexa NDA is October 28, 2010.
VIVUS is a biopharmaceutical company developing therapies to address unmet needs in obesity, sleep apnea, diabetes, and sexual health. The company’s lead product in clinical development, Qnexa, has completed phase 3 clinical trials for the treatment of obesity. Qnexa is also in phase 2 clinical development for the treatment of type 2 diabetes and obstructive sleep apnea.
"Review by the Advisory Committee represents a critical milestone for Qnexa and for VIVUS. We believe Qnexa, if approved, could become a treatment option for obese patients," stated Leland Wilson, CEO of VIVUS. "We look forward to discussing the efficacy and safety data of Qnexa with the members of the Endocrinologic and Metabolic Drugs Advisory Committee."
