SILVER SPRING, Md.--After the U.S. Food and Drug Administration (FDA) approved semaglutide 2.4 mg weekly injection (Wegovy®) on June 4, 2021 for chronic weight management in adults with overweight or obesity, past presidents of The Obesity Society (TOS) are weighing in on its implications for the effective treatment of obesity.
"The approval of semaglutide 2.4 is an important development in the effort to control the epidemic of obesity," said Lee M. Kaplan, MD, PhD, director of the Obesity, Metabolism and Nutrition Institute at Massachusetts General Hospital in Boston, Mass. "The research studies supporting its approval demonstrated that this medication is nearly twice as effective as the best of the drugs currently on the market, leading to weight loss that averages more than 15 percent after one year. With this degree of long-term weight loss, we can anticipate improvement in many of the more than 200 diseases that are caused or worsened by obesity."
Semaglutide 2.4 is indicated for chronic weight management in patients with a body mass index (BMI) of 30 kg/m2 or greater or a BMI of 27 kg/m2 or greater who have at least one weight-related comorbidity such as high blood pressure, high cholesterol, fatty liver disease, sleep apnea or type 2 diabetes. This injectable therapy is the first, newly-approved, anti-obesity medication since 2014.
Semaglutide 2.4 works by mimicking a hormone called glucagon-like peptide-1 (GLP-1), which naturally regulates areas of the brain that control appetite and food intake. The medication dose must be increased gradually over 16-to-20 weeks to 2.4 mg once weekly to reduce gastrointestinal side effects.
"Wegovy will likely be the first of a few up-and-coming agents that will help close the treatment gap between anti-obesity medications and bariatric surgery," said Caroline M. Apovian, MD, co-director of the Center for Weight Management and Wellness at Brigham and Women's Hospital and a member of the faculty at Harvard Medical School in Boston, Mass. "This new agent provides nearly double the weight loss (10 to 20 percent) as current agents on the market (5 to 10 percent) inching closer to the robust weight loss of 25 to 30 percent seen with bariatric surgery."
The medication should not be used in combination with other semaglutide-containing products such as Ozempic® or Rybelsus®, other GLP-1 receptor agonists, or other products intended for weight loss, including prescription drugs, over-the-counter drugs or herbal products. It has not been studied in patients with a history of pancreatitis.
The safety and efficacy of semaglutide 2.4 were studied in four, 68-week randomized controlled trials. Two of these trials examined the safety and effectiveness of semaglutide in patients with and without diabetes. One looked at the effect of the medication with and without concurrent intensive behavioral therapy, and one determined the effect of continuing or withdrawing the drug after an initial period of weight loss. In these four trials, more than 2,600 patients received semaglutide 2.4 for up to 68 weeks and more than 1,500 patients received placebos.
The most common side effects of semaglutide 2.4 included nausea, vomiting, and diarrhea that were most common during the first several weeks of treatment and tended to abate thereafter. Less common side effects included other gastrointestinal symptoms such as constipation, abdominal pain, headache, fatigue, indigestion, lightheadedness, belching, gastroesophageal reflux, as well as low blood sugar in patients with type 2 diabetes.
"This is by far the most effective intervention we have seen for weight management when you compare it to many of the currently existing drugs. Semaglutide sets the bar for a new generation of more effective hormonally-based weight loss medications," said Robert F. Kushner, MD, professor, Departments of Medicine and Medical Education at Northwestern University Feinberg School of Medicine in Chicago.
Approximately 70 percent of American adults have obesity or pre-obesity (another term for overweight). Obesity and pre-obesity are serious health conditions that promote several of the leading causes of death, including heart disease, stroke, diabetes and several common cancers. Long-term weight loss is associated with a reduction in these risks.
The Obesity Society (TOS) is the leading organization of scientists and health professionals devoted to understanding and reversing the epidemic of obesity and its adverse health, economic and societal effects. Combining the perspective of researchers, clinicians, policymakers and patients, TOS promotes innovative research, education and evidence-based clinical care to improve the health and well-being of all people with obesity. For more information, visit http://www.obesity.org.