FDA Positioned to Approve New Weight Loss Drug, First in a Decade

There is new hope for the more than one-third of the US population battling obesity, after the FDA panel reviewing the data voted 18 to 4 last week in favor of the obesity drug candidate, lorcaserin.  Upon final approval in late June, lorcaserin, or Lorquess as the new drug will be called, will be the first FDA approved drug for weight loss since 1999. 

In recent weeks, weight loss treatment options have been a popular topic in the news.  A study released by the New England Journal of Medicine in March found that people who had weight loss surgery were dramatically more successful at treating and possibly eliminating their Type 2 diabetes, than those who continued diet changes and medication alone.  This news supported what many bariatric surgeons have witnessed with their own patients, including Bailey Bariatric’s Dr. JoeBob Kirk. 

With obesity and diabetes continuing to rise and become an epidemic among children and young adults, weight loss management, whether via a new weight loss drug or surgery, continues to be top of mind for many.  Bailey Bariatric’s Dr. Brandon Varnell warns the public should not be misguided to believe Lorquess will be the answer to all their problems. “Morbid obesity is a complex, multi-factorial disease process that continues to not allow any one simple fix to be invented," Dr. Varnell explains.  "This drug," Dr. Varnell says, "like all of its predecessors, has many side effects and must be taken life-long to sustain results.” 

In fact, the FDA may require an additional study to review the cardiovascular effects of the drug.  While an increased risk of cardiovascular adverse events could not be ruled out by the committee, administrators decided it was not fair to change the rules halfway through the study and require a CV events study prior to approval.

Dr. Varnell examined the study, comparing results with use of this new drug to surgical outcomes, “In clinical trials its success was marginal, with only 10% excess weight loss on average.  This compared to 50-80% excess weight loss seen with surgical modalities.”  Dr. Varnell believes if Lorquess gets the final FDA approval, it will be better suited as one treatment within an overall plan for weight loss, “It will find use as an adjunct to weight loss, or for those wanting only subtle weight change.”  

For obese (BMI of 30 or greater) and overweight patients (BMI of 27 or greater) with at least one co-morbid condition, the potential impact of Lorquess should be understood with realistic expectations for improving overall health.  As the initial trials indicate, a 10% reduction in excess weight loss compliments, but is not responsible for a dramatic improvement in patients’ health.  “We know it's no longer about the weight, but the health, comorbidities, and longevity that comes along with morbid obesity,” Dr. Varnell explains.  “We also know that often a 40% or more excess weight loss is required to improve or better yet resolve these many associated health problems,” Dr. Varnell concludes.

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