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News from related pharmaceutical companies, the US Food and Drug Administration (FDA) recently approved the weekly preparation of semeglutide for the treatment of obesity (BMI ≥95th quantile, based on CDC growth chart) in adolescents aged 12~17 years, with diet and exercise
.
In June 2022, Semeglutide received FDA approval for weight management in adult patients who are overweight/obese and have at least one weight-related disease, the first drug
approved for weight management in adult obese patients since 2014.
About 6 months apart, the obesity-related indications for semeglutide were expanded
again.
"The prevalence of adolescent obesity in the United States continues to rise, affecting patients and their families," Dr.
Aaron S.
Kelly, associate director of the University of Minnesota Center for Pediatric Obesity, said at a press conference.
The approval of a new indication for semeglutide periphosphate provides patients with a new option to address this severe chronic progressive disease
.
”
Weight loss effect
In the STEP TEENS Phase 3a clinical trial, semeglutide showed significant weight loss in obese adolescents
.
A total of 201 obese adolescents were randomized to either once-weekly semeglutide (2.
4 mg, n=134) or placebo (n=67) for 68 weeks
.
At the end of the trial, mean BMI decreased by 16.
1% in the semeglutide group and 0.
6%
in the placebo group.
In addition, 73% of adolescents in the semeglutide group lost ≥5% of their body weight, compared with only 20%
in the placebo group.
Adverse reactions
Overall, adolescent participants in the STEP TEENS study reported adverse events similar
to those previously reported by adults.
The most common adverse effects were nausea, vomiting, diarrhoea, headache, and abdominal pain; Adolescents taking semeglutide had a higher
chance of gallbladder problems, hypotension, rash, and itching compared with adults using the drug.
Information source:
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