Basic Information
Wegovy
Regulatory Information
EMEA/H/C/005422
January 6, 2022
November 11, 2021
11
January 8, 2025
Company Information
Denmark
Novo Alle 1 2880 Bagsvaerd
Novo Nordisk A/S
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Adults Wegovy is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of • ≥30 kg/m2 (obesity), or • ≥27 kg/m2 to <30 kg/m2 (overweight) in the presence of at least one weight-related comorbidity e.g. dysglycaemia (prediabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease. For trial results with respect to cardiovascular risk reduction and populations studied, see section 5.1. Adolescents (≥12 years) Wegovy is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adolescents ages 12 years and above with • obesity\* and • body weight above 60 kg. Treatment with Wegovy should be discontinued and re-evaluated if adolescent patients have not reduced their BMI by at least 5% after 12 weeks on the 2.4 mg or maximum tolerated dose. \*Obesity (BMI ≥95th percentile) as defined on sex- and age-specific BMI growth charts (CDC.gov) (see Table 1 in 4.1 of SmPC). Table 1 BMI cut-off points for obesity (≥95th percentile) by sex and age for paediatric patients aged 12 and older (CDC criteria)
Overview Summary
Wegovy is used together with diet and physical activity to help people to lose weight and keep their weight under control. It is used in adults who have: • a BMI of 30 kg/m² or greater (obesity) or • a BMI of at least 27 kg/m² but less than 30 kg/m² (overweight) who have weight-related health problems (such as diabetes, high blood pressure, abnormal levels of fats in the blood, breathing problems during sleep called ‘obstructive sleep apnoea’ or a history of heart attack, stroke or blood vessel problems). It is also used in adolescents from 12 years of age whose BMI is at or above the 95th percentile for their age and gender (obesity) and who weigh more than 60 kg. BMI (body mass index) is a measure of your weight in relation to your height. A BMI at the 95th percentile means that it is greater than that of 95% of people of the same age and gender. Wegovy contains the active substance semaglutide.