麻豆传媒

Novo Nordisk's injectable 3-mg liraglutide (Saxenda) was approved for chronic weight management in teens with obesity, the late Friday.

The GLP-1 receptor agonist, which was first approved for adults in December 2014, is now a treatment option for adolescents with obesity ages 12-17 as adjunct to diet and exercise.

More specifically, expanded indication now includes teens with a body weight greater than 132 lb (60 kg) and BMI of 30 or higher, and the once-daily treatment is to be injected in the patients' abdomen area, thigh, or upper arm.

This label expansion was based on positive 56-week phase IIIa data presented at the virtual ENDO meeting this March and simultaneously published in the New England Journal of Medicine, showing greater relative change in BMI (-4.64 percentage points) and body weight (-4.50 kg) among adolescents on liraglutide plus lifestyle therapy versus diet and exercise alone.

"The degree of BMI reduction with 3 mg liraglutide in the adolescent trial appears to compare favorably to orlistat [Xenical, Alli], a medication currently approved by the [FDA] for adolescents ages 12 to less than 18 years old," lead investigator Aaron S. Kelly, PhD, of the University of Minnesota in Minneapolis, previously told 麻豆传媒.

Gastrointestinal side effects were the most common adverse events reported in the trial, which included nausea, vomiting, diarrhea, dizziness, and fever.

The treatment should not be used in conjunction with any other liraglutide products, such as Victoza indicated for type 2 diabetes, nor any other GLP-1 receptor agonist products including dulaglutide (Trulicity), exenatide (Bydureon, Byetta), semaglutide (Ozempic, Rybelsus), or lixisenatide (Adlyxin). The FDA warned it also shouldn't be used in combination with any other weight loss products.

Saxenda also carries the same boxed warning on thyroid C-cell tumors that other liraglutide products likewise carry.

"With up to 90% of adolescents with obesity likely to have it as adults and thus at increased risk for developing weight-related complications, it's important to address weight care and offer support early on," Kelly said in a on the new approval. "I'm encouraged that healthcare providers now have another tool in developing a personalized, complete care plan to help adolescents lose weight and keep it off."

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