BRIEF—New FDA label approval for Wegovy

Denmark’s Novo Nordisk last week announced that the US Food and Drug Administration (FDA) has approved a new indication for Wegovy (semaglutide) injection 2.4mg, making it the first-and-only prescription anti-obesity medicine for teens with once-weekly dosing.

Wegovy is now also indicated for use in adolescents (≥ 12 years old) with an initial body mass index (BMI) at or above the 95th percentile for age and sex (based on CDC growth charts) along with a reduced calorie meal plan and increased physical activity to lose weight and keep it off.

The approval was based on the Phase IIIa STEP-TEENS study, in which Wegovy allowed a 16.1% decrease in BMI, versus a 0.6% increase with placebo.

“The prevalence of teen obesity in the US continues to rise, affecting teens and their families. Now, more than ever, we need new options to support teens,” said Aaron Kelly, co-director of the Center for Pediatric Obesity Medicine at the University of Minnesota, adding: “This FDA approval offers an additional tool to address this serious, chronic, progressive disease.”

Novo Nordisk has been experiencing supply shortages of the drug, but said it is on track to make all dose strengths of Wegovy available in the USA by the end of the year.