FDA Approves Wegovy (Semaglutide) for obesity in teens 12 and Up - Medscape

the united states food and Drug Administration has approved semaglutide 2.four mg (Wegovy), a as soon as-weekly subcutaneous injection, for the further indication of treating obesity in teenagers aged 12 years and older.

this is described as those with an initial BMI at or above the ninety fifth percentile for age and intercourse (in line with CDC increase charts). Semaglutide have to be administered along with subculture intervention of a decreased calorie meal plan and improved physical undertaking.

When Wegovy turned into permitted for use in adults with obesity in June 2021, it turned into labeled a "game changer."

the new approval is in line with the consequences of the STEP young adults part three trial of as soon as-weekly 2.4 mg of semaglutide in youngsters 12- to <18 years old with weight problems, the drug's brand, Novo Nordisk, introduced in a statement.

In STEP teenagers, stated at weight problems Week 2022 in November, and concurrently posted in the New England Journal of medicine, youth with obesity treated with semaglutide for 68 weeks had a 16.1% discount in BMI compared with a 0.6% increase in BMI in those receiving placebo. both groups additionally received culture intervention. suggest weight loss become 15.3 kg (33.7 lb) among young adults on semaglutide, while these on placebo gained 2.4 kg (5.three lb).

at the time, Claudia okay. Fox, MD, MPH, co-director of the center for Pediatric weight problems medicine on the tuition of Minnesota medical college â€" who become now not involved with the analysis â€" told Medscape the results were "outstanding…we are getting close to bariatric surgery results" in these adolescent sufferers with obesity.

Semaglutide is a GLP-1 agonist, as is a related agent, additionally from Novo Nordisk, liraglutide (Saxenda), a regular subcutaneous injection, which become accredited for use in adolescents aged 12 and older in December 2020. Wegovy is the first weekly subcutaneous injection authorised for use in adolescents.

different agents authorized for obesity in these older than 12 within the US consist of the combination phentermine and topiramate prolonged-free up drugs (Qsymia) in June 2022, and orlistat (Alli). Phentermine is authorized for these aged sixteen and older.  

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