Health
Wegovy OK for Obese Teens
The FDA has approved injectable semaglutide 2.4 mg (Wegovy) for obese patients 12 years and older. Novo Nordisk announced.
When combined with diet and exercise, it is now available for adolescents with an initial BMI for age and gender above the 95th percentile based on CDC growth charts. This new indication for a GLP-1 receptor agonist is the first once-weekly anti-obesity drug for teenagers.
Aaron Kelly, Ph.D., co-director of the Pediatric Obesity Medical Center, said: Novo his Nordisk statement at the University of Minnesota. “His FDA approval now provides an additional tool to address this serious, chronic, and progressive disease.”
The basis for approval is Phase IIIa STEP TEENS study Announced in 2022 ObesityWeek Annual MeetingAfter 68 weeks of treatment, BMI decreased by an average of 16.1% from baseline in the semaglutide group compared to a 0.6% increase in the placebo group (P.<0.001).
Teenagers taking semaglutide lost an average of 15.3 kg (33.7 lbs), while teenagers taking placebo gained 2.4 kg (5.3 lbs) over 68 weeks.
A total of 73% of participants in the semaglutide group experienced a weight loss of 5% or more compared to 18% of participants in the placebo group (P.<0.001); 62% vs. 8% had a weight loss of ≥10% and 37% vs. 3% had a weight loss of ≥20%, respectively.
“The extent of the weight loss is unprecedented. MedPage Today at a meeting. “Suddenly, after years of frustration, patients actually lost weight. They had never seen it before.”
Other measures such as total cholesterol (-8.3% vs -1.3%), VLDL triglycerides (-28.4% vs -2.6%) and alanine transaminase levels (-18.3% vs -4.9%) were also observed in the semaglutide group compared to placebo. significantly improved. %).
Side effects were similar to those seen in the adult population of GLP-1 receptor agonists, including nausea, vomiting, diarrhea, headache, and abdominal pain. had a higher incidence of gallbladder problems such as gallstones, hypotension, rashes, and itching compared with
A “game-changing” agent First Approved for Chronic Weight Management It will be approved for adults in June 2021, making it the first drug approved for this indication since 2014.
After approval, there was huge demand for agents complicated by numerous supply chain issues. Nationwide shortage. but, Product US websitewas updated Wednesday, stating that “all Wegovy dose strengths are now available in retail pharmacies nationwide,” and that the company will “increase production capacity in 2023, closely monitor prescribing trends, We are assessing demand,” he said.
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