Glass and Light

The Year Ahead for Six New Obesity Treatments

New obesity treatments promise to provide interesting news in the coming year. Two new drugs and at least one more medical device will come before FDA for approval this year. Other new treatments are in various stages of development. It’s hardly a flood of innovation, but considering how empty the toolbox is for treating obesity and how barren the obesity innovation landscape was a few years ago, things are looking up.

Here’s a quick rundown of what’s in the offing.

  1. Contrave. This combination of buproprion and naltrexone won a vote for approval from an FDA advisory committee in 2010, but it got snagged by new FDA requirements to conduct cardiovascular outcome trials for some endocrinology and obesity drugs. Now the study is done, the results were good, and Orexigen has filed again for Contrave’s approval with FDA. Fingers crossed, approval could happen by the end of 2014.
     
  2. Liraglutide. Without a lot of fanfare, Novo Nordisk submitted liraglutide for the treatment of obesity in December. Already marketed at a lower dose for type 2 diabetes under the brand name Victoza, approval for obesity is possible, but by no means certain in 2014. Novo Nordisk, a stalwart of diabetes treatment, appears to be taking a steady, conservative approach to obesity that could serve the company well.
     
  3. Beloranib. This new molecule for obesity treatment burst onto the scene in late 2013 with phase 2 study results creating a flurry of excited press reports. The new biotech start-up behind this drug, Zafgen, has just raised another $45 million to fund phase 3 trials in severe obesity. Though the early data is impressive, time will tell if the encouraging results hold up in larger trials.
     
  4. Maestro VBLOC System. EnteroMedics has been through a lot of ups and downs with its Maestro implantable system for vagal blockade to treat obesity. The latest boost for the company came in early December when with the release of 18-month clinical results and reports that the company had responded to FDA questions. An advisory committee hearing is likely in the first half of the year. If the hearing outcome is favorable, the Maestro System could be the third obesity treatment approved in 2013.
     
  5. Gastric Balloons. These devices for obesity treatment have been in use outside of the U.S. for many years now. Apollo Endosurgery acquired rights to the Orbera intragastric balloon with the rest of Allergan’s obesity business. ReShape Medical recently announced completion of a successful pivotal, sham-controlled study of their intragastric balloon for obesity treatment and plans to seek FDA approval in the second quarter of 2014. Allurion Technologies is yet another, early-stage company with a unique intragastric balloon device under development. You can expect considerable activity in this segment during 2014.
     
  6. EndoBarrier. GI Dynamics is in the midst of a pivotal trial of this duodenal-jejunal bypass sleeve to support an FDA submission in 2015.

 
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Glass and Light, photograph © BlueRidgeKitties / flickr

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