FDA approves once-weekly semaglutide for adolescents with obesity
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The FDA approved once-weekly semaglutide for the treatment of obesity among adolescents aged 12 to 17 years with an initial BMI in the 95th percentile for age and sex, according to a press release.
The FDA’s new indication for semaglutide (Wegovy, Novo Nordisk) comes a little more than 18 months after the medication was initially approved in June 2021 for chronic weight management in adults with obesity or with overweight plus one weight-related condition. As Healio previously reported, semaglutide was the first drug to be approved for chronic weight management for adults with obesity since 2014.
“The prevalence of teen obesity in the U.S. continues to rise, affecting teens and their families,” Aaron S. Kelly, PhD, co-director of the University of Minnesota Center for Pediatric Obesity Medicine, said in a press release. “Now, more than ever, we need new options to support teens. This FDA approval offers an additional tool to address this serious, chronic, progressive disease.”
As Healio previously reported, semaglutide conferred significant weight loss in a cohort of adolescents with obesity in the STEP TEENS phase 3a clinical trial. In the trial, 201 adolescents with obesity were randomly assigned to once-weekly semaglutide 2.4 mg plus lifestyle intervention (n = 134) or placebo (n = 67) for 68 weeks. At the end of the trial, the semaglutide group had a BMI reduction of 16.1% compared with a BMI increase of 0.6% in the placebo group. Additionally, 73% of adolescents in the semaglutide group lost 5% or more of their body weight compared with 18% of the placebo group.
The adverse events reported in STEP TEENS were similar to those previously reported among adults. The most common adverse events for adolescents were gastrointestinal disorders, reported by 62% of those in the semaglutide group. Adolescents using semaglutide had greater incidences of gallbladder problems, low blood pressure, rash and itching compared with adults using the medication.
Semaglutide is approved for use for adolescents with obesity in conjunction with a reduced calorie meal plan and increased physical activity. Novo Nordisk announced it planned to make all dose strengths of semaglutide available in the U.S. by the end of 2022, according to the press release.
Perspective
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The approval of once-weekly semaglutide for adolescents aged 12 years and older marks another milestone and a big step forward for the treatment of obesity in the pediatric population. Semaglutide has now become the third medication — along with liraglutide and combination phentermine/topiramate extended release — in the past 2 years that the FDA has approved for chronic weight management in this population. Having an option like semaglutide, which resulted in a mean 16.1% reduction in BMI in adolescents with obesity over 68 weeks in the STEP TEENS trial, should be extremely encouraging to providers who treat adolescents with obesity. Never before have we seen this kind of BMI reduction with a weight loss medication in adolescents.
Moreover, the trial also demonstrated an improvement in weight-related quality of life, which has not been seen in other weight-loss medication trials in this age group. While there remain questions about long-term safety in adolescents, there is no question that we will need more tools, like semaglutide, to mitigate the rising rates of pediatric obesity and its associated comorbidities. Let’s be sure we don’t take two steps back and instead work toward expanding access to semaglutide and other medication options for adolescents with obesity.
Reference:
FDA approves once-weekly Wegovy injection for the treatment of obesity in teens aged 12 years and older. Available at: www.novonordisk-us.com/content/nncorp/us/en_us/media/news-archive/news-details.html?id=151389. Published Dec. 23, 2022. Accessed Jan. 9, 2023.
Perspective
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In December 2020, liraglutide was approved by the FDA for treatment of obesity in adolescents. Phentermine/topiramate extended-release capsules received similar FDA approval in June 2022. Both medications are significant advances compared to the previous options of orlistat and phentermine, with regard to efficacy and tolerability.
The FDA’s approval of once-weekly semaglutide for the treatment of adolescents with obesity will enable health care providers to have another treatment option available for our younger patient population. Just as importantly, this approval provides additional evidence that pharmacologic management of teen obesity is rigorously tested, safe and effective. The maturation of this field of medicine continues and is cause for optimism for patients, their families and their physicians.
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