FDA approves diabetes drug semaglutide for weight loss in teens
FDA approves diabetes drug semaglutide for weight loss in teens
ISLAMABAD (ONLINE) - The US Food and Drug Administration has approved the diabetes drug Wegovy (semaglutide) to treat obesity in teens, according to Novo Nordisk, which makes Wegovy.
The news comes weeks after a study found that the obesity and type 2 diabetes drug semaglutide is just as effective in adolescents with obesity as it is in adults with obesity.
The drug is injected once a week and is used under the brand names of Ozempic and Wegovy.
Wegovy has been approved to treat children as young as 12, according to Novo Nordisk.
Approval comes after major study
The study, which was published in The New England Journal of Medicine in December, found that adolescents with obesity who took the drug and practiced lifestyle interventions experienced a 16% reduction in body mass index (BMI) within 68 weeks.
The drug also led to improvements in cardiometabolic health issues.
Semaglutide, a glucagon-like peptide-1 analogue, is currently only approved for adults with obesity or obesity-related health conditions. It works by suppressing appetite, which then reduces caloric intake and leads to weight loss.
The researchers say the new findings shed light on a promising new treatment option for adolescents with obesity — especially at a time when childhood obesity rates are soaring.
“I am hopeful that this will be a real breakthrough. We still need more studies to support its efficacy as well as more insurance companies willing to cover it,” Dr. Gina Posner, a board-certified pediatrician at MemorialCare Orange Coast Medical Center in Fountain Valley, CA, told Healthline.
Semaglutide worked better than other weight-loss drugs
The researchers compared the effectiveness of semaglutide to a placebo in 201 adolescents with obesity between the ages of 12 through 17.
In the study, 134 of the participants received 2.4 milligrams of semaglutide subcutaneously once a week and adhered to lifestyle interventions for 68 weeks. Among the total participants, 67 received a placebo and adhered to lifestyle interventions for 68 weeks.
After the treatment period, the research team tracked the health of the participants for an additional seven weeks.
They found that those who took semaglutide experienced a 16.1% reduction in BMI compared to their baseline BMI. Those who took the placebo had a very slight increase in BMI.
In addition, 73% of those who took semaglutide lost at least 5% of their body weight compared to 18% of those who took the placebo.
They also experienced improvements in various cardiometabolic risk factors, including lipids, cholesterol, triglycerides, waist circumference, and glycated hemoglobin levels.
Those who took semaglutide and experienced weight loss also reported better quality of life.
Similar to adults, the most common adverse effects of semaglutide in adolescents were gastrointestinal issues, but the symptoms were mild and short-lived.
According to the researchers, the benefits of semaglutide were significantly greater than the other weight-loss drugs approved for adolescents with obesity.
But, other trials comparing semaglutide to other weightloss drugs for adolescents have not yet been carried out.
How childhood obesity is currently treated
Current guidelines for young people with obesity recommend multiple lifestyle interventions, however, research has generally found that it’s more difficult to achieve long-lasting weight loss results with lifestyle interventions once obesity has occurred
If young people are unable to achieve their weight loss goals through lifestyle interventions, pharmaceutical medications are available, but the options are limited.
The US Food and Drug Administration (FDA) had already approved three weight loss drugs for adolescents with obesity —liraglutide (Victoza), orlistat (Alli, Xenical), and phentermine–topiramate (Qsymia).
“Besides lifestyle interventions, there are not much other options — besides meds that are used for only very specific medical indications,” says Dr. Daniel Ganjian, a pediatrician at Providence Saint John’s Health Center in Santa Monica, CA.