FDA Panel Approves Mountain View Company’s Previously Rejected Diet Pill

MOUNTAIN VIEW (CBS/AP) – A panel of advisers to the Food and Drug Administration overwhelmingly backed approval for a highly anticipated anti-obesity pill from Mountain View-based Vivus Inc., a drug which the FDA previously rejected due to safety concerns.

The FDA panel of outside physicians voted 20-2 in favor of the weight loss drug Qnexa, setting the stage for a potential comeback for a drug that has been plagued by side effects since it was first submitted to the agency in 2010.

In 2010, the FDA rejected this drug amid safety concerns. Vivus developed the drug and presented additional data on the drug to the FDA advisory committee. On Tuesday, CBS 5’s Dr. Kim Mulvihill reported on Onexa, and the ongoing search for get-slim-quick pills.

A majority of panelists ultimately backed the drug due to its impressive weight loss results, with most patients reporting nearly 10 percent weight loss. But the group stressed the importance of confirming the drug’s safety, particularly its effects the heart, by tracking patients in a large, follow-up study. FDA’s decision is expected in April.

(Copyright 2012 by CBS San Francisco. All Rights Reserved. This material may not be published, broadcast, rewritten, or redistributed.)

  • http://sanfrancisco.cbslocal.com/2012/04/09/fda-will-take-3-more-months-to-review-mountain-view-firms-diet-pill/ FDA Will Take 3 More Months To Review Mountain View Firm’s Diet Pill « CBS San Francisco

    […] But Vivus resubmitted the drug and it received a surprisingly positive 20-2 favorable vote from a panel of medical advisers in February. […]

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