The Wall Street Journal
Vivus Inc. said a Food and Drug Administration advisory committee is tentatively set to review the company's new-drug application for its experimental Qnexa obesity treatment.
Chief Executive Leland Wilson said the July 15 review will mark a critical milestone for Qnexa and the company.
Vivus is one of three drug developers hoping to get regulatory approval of new oral obesity treatments, along with Orexigen Therapeutics Inc. and Arena Pharmaceuticals Inc. Vivus earlier this year also said that Qnexa was shown to reduce sleep apnea, when breathing stops briefly during sleep, by 69% in a midstage trial.
While the sleep-apnea data were preliminary and based on a small set of patients, the results could help Qnexa eventually become the first drug for the condition, currently treated only by devices, and may further bolster Vivus's resume in its search for a large pharmaceutical company partner for the antiobesity drug. Vivus would need FDA approval to market a drug for that use.
Qnexa is a combination of weight-loss drug phentermine and controlled release topiramate, sold as Topamax by Johnson & Johnson.
Chief Executive Leland Wilson said the July 15 review will mark a critical milestone for Qnexa and the company.
Vivus is one of three drug developers hoping to get regulatory approval of new oral obesity treatments, along with Orexigen Therapeutics Inc. and Arena Pharmaceuticals Inc. Vivus earlier this year also said that Qnexa was shown to reduce sleep apnea, when breathing stops briefly during sleep, by 69% in a midstage trial.
While the sleep-apnea data were preliminary and based on a small set of patients, the results could help Qnexa eventually become the first drug for the condition, currently treated only by devices, and may further bolster Vivus's resume in its search for a large pharmaceutical company partner for the antiobesity drug. Vivus would need FDA approval to market a drug for that use.
Qnexa is a combination of weight-loss drug phentermine and controlled release topiramate, sold as Topamax by Johnson & Johnson.
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