FDA Approves Wegovy (Semaglutide) for Weight problems in Teenagers 12 and Up

The US Meals and Drug Administration has accepted semaglutide 2.4 mg (Wegovy), a once-weekly subcutaneous injection, for the extra indication of treating weight problems in adolescents aged 12 years and older.

That is outlined as these with an preliminary BMI at or above the ninety fifth percentile for age and intercourse (primarily based on CDC progress charts). Semaglutide have to be administered together with way of life intervention of a decreased calorie meal plan and elevated bodily exercise.

When Wegovy was accepted to be used in adults with weight problems in June 2021, it was labeled a “sport changer.”

The brand new approval is predicated on the outcomes of the STEP TEENS section 3 trial of once-weekly 2.4 mg of semaglutide in adolescents 12- to <18 years previous with weight problems, the drug’s producer, Novo Nordisk, introduced in a press launch.

In STEP TEENS, reported at Weight problems Week 2022 in November, and concurrently revealed within the New England Journal of Drugs, adolescents with weight problems handled with semaglutide for 68 weeks had a 16.1% discount in BMI in contrast with a 0.6% enhance in BMI in these receiving placebo. Each teams additionally acquired way of life intervention. Imply weight reduction was 15.3 kg (33.7 lb) amongst teenagers on semaglutide, whereas these on placebo gained 2.4 kg (5.3 lb).

On the time, Claudia Ok. Fox, MD, MPH, co-director of the Heart for Pediatric Weight problems Drugs on the College of Minnesota Medical Faculty — who was not concerned with the analysis — informed Medscape the outcomes had been “mind-blowing…we’re getting near bariatric surgical procedure outcomes” in these adolescent sufferers with weight problems.

Semaglutide is a GLP-1 agonist, as is a associated agent, additionally from Novo Nordisk, liraglutide (Saxenda), a every day subcutaneous injection, which was accepted to be used in adolescents aged 12 and older in December 2020. Wegovy is the primary weekly subcutaneous injection accepted to be used in adolescents.

Different brokers accepted for weight problems in these older than 12 within the US embrace the mixture phentermine and topiramate extended-release capsules (Qsymia) in June 2022, and orlistat (Alli). Phentermine is accepted for these aged 16 and older.  

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