Ulverstone Scoreboard

2014 FDA Obesity Scorecard: Drugs 2, Devices 0

With the books closed on FDA obesity approvals for 2014, the scorecard shows drugs coming out ahead of devices by a margin of two to nothing. Both Contrave (buproprion/naltrexone) and Saxenda (liraglutide) won final approval for treating obesity in the second half of 2014.

Left waiting on the sidelines was the Maestro VBLOC device, which received a mixed, but positive review from an FDA advisory committee in June. The committee voted that this device, which blocks the vagus nerve to treat obesity, has benefits that outweigh its risks. Observers expected a year-end approval from FDA, but it never came. The delay is testing the patience of investors in Enteromedics, the company that has spent years developing the VBLOC technology.

It’s now been more than a decade since FDA approved any new medical device for obesity. A number of innovators are lining up to submit new technology to FDA for obesity treatment. But funding for such innovation will quickly be snuffed out if none of these devices can make it through FDA to approval.

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Ulverstone Scoreboard, photograph © Leo Laporte / flickr

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