The FDA mentioned it’s the first authorised drug for power weight administration in adults with common weight problems or obese since 2014.
This story has been corrected to notice the indications for semaglutide.
The FDA Friday authorised semaglutide as a weight administration drug in adults with sure comorbidities when used together with a lowered calorie weight loss program and elevated bodily exercise.
It’s the first authorised drug for power weight administration in adults with common weight problems or obese since 2014, the FDA mentioned. Semaglutide is indicated for power weight administration in sufferers with a physique mass index (BMI) of 27 kg/m2 or higher who’ve at the least 1 weight-related situation, reminiscent of the kind 2 diabetes (T2D), hypertension, or excessive ldl cholesterol, or alone in sufferers with a BMI of 30 kg/m2 or higher with out weigh-related illnesses.
For this indication, the two.4-mg once-weekly injection will likely be offered below the title Wegovy. The approval was granted to Novo Nordisk. As a 1-mg injection, the drug is offered as Ozempic and was first authorised as a remedy for T2D in 2017.
“Right now’s approval gives adults with weight problems or obese a helpful new remedy possibility to include right into a weight administration program,” mentioned John Sharretts, MD, deputy director of the Division of Diabetes, Lipid Problems, and Weight problems within the FDA’s Heart for Drug Analysis and Analysis, in an announcement.
Semaglutide works by mimicking a hormone known as glucagon-like peptide-1 (GLP-1) that targets areas of the mind that regulate urge for food and meals consumption. The dose should be elevated progressively over 16 to twenty weeks to 2.4 mg as soon as weekly to scale back gastrointestinal unwanted effects.
Security and efficacy have been studied in 4 68-week trials. Three have been randomized, double-blind, placebo-controlled trials (together with 16 weeks of dose will increase) and one was a double-blind, placebo-controlled, randomized withdrawal trial through which sufferers receiving semaglutide both continued with the remedy or switched to a placebo. Greater than 2600 sufferers acquired semaglutide for as much as 68 weeks in these 4 research; greater than 1500 sufferers acquired placebo.