麻豆传媒

The FDA approved injectable semaglutide 2.4 mg (Wegovy) for people with obesity ages 12 and up, maker .

When paired with diet and exercise, it's now indicated for use in adolescents with an initial BMI at or above the 95th percentile for age and sex based on CDC growth charts. This new indication for the GLP-1 receptor agonist marks the first anti-obesity medicine for teens with once-weekly dosing.

"The prevalence of teen obesity in the U.S. continues to rise, affecting teens and their families. Now, more than ever, we need new options to support teens," said Aaron Kelly, PhD, co-director of the Center for Pediatric Obesity Medicine at the University of Minnesota, in Novo Nordisk's statement. "This FDA approval offers an additional tool to address this serious, chronic, progressive disease."

Underpinning the approval is the phase IIIa STEP TEENS trials presented at the 2022 ObesityWeek annual meeting. After 68 weeks of treatment, BMI declined an average 16.1% from baseline with semaglutide versus a 0.6% increase with placebo (P<0.001).

Mean weight loss was 15.3 kg (33.7 lb) among teens on semaglutide, while those on placebo gained 2.4 kg (5.3 lb) at 68 weeks.

A total of 73% of the semaglutide group had weight loss of 5% or more compared with 18% of participants in the placebo group (P<0.001); 62% versus 8%, respectively, had weight loss of 10% or more, and 37% versus 3% had weight loss of 20% or more.

"The degree of body weight reduction is unprecedented," lead study author Daniel Weghuber, MD, of Paracelsus Medical University in Salzburg, Austria, told 麻豆传媒 at the meeting. "After years of frustration, all of a sudden patients were actually losing weight. They'd never seen that before."

Other measures also improved significantly in the semaglutide group compared with the placebo group, including total cholesterol (-8.3% vs -1.3%), VLDL triglycerides (-28.4% vs 2.6%), and alanine transaminase levels (-18.3% vs -4.9%).

Adverse effects were similar to those seen in the adult population with GLP-1 receptor agonists, including nausea, vomiting, diarrhea, headache, and abdominal pain. Teens on semaglutide had higher rates of gallbladder problems including gallstones, low blood pressure, rash, and itching compared with adults on the treatment.

The "game changing" agent was first approved for chronic weight management in adults in June 2021, making it the first drug approved for this indication since 2014.

Following its approval, there has been immense demand for the agent complicated by a slew of supply chain issues -- thus leading to nationwide shortages. However, , updated Wednesday, states that "all dose strengths of Wegovy are now available to retail pharmacies nationwide" and that the company is "increasing our production capacity in 2023, closely monitoring prescribing trends and assessing demand."

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