Wegovy (semaglutide)
- Region
- 🇪🇺 EU
- Active substance
- semaglutide
- Company
- Novo Nordisk A/S
- Status
- Authorised
- Therapeutic area
- Obesity; Overweight
- CHMP opinion
- Thu 11 Nov 2021
- EU approval
- Thu 06 Jan 2022
- Application
- EMEA/H/C/005422
- ATC
- A10BJ06
- Official record
- www.ema.europa.eu
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)
Regulatory milestones
FDA approves Wegovy (semaglutide): new dosage form
Same substance in other markets
- 🇪🇺 Ozempic Authorised · Novo Nordisk A/S
- 🇪🇺 Kayshild Authorised · Novo Nordisk A/S
- 🇪🇺 Rybelsus Authorised · Novo Nordisk A/S
- 🇪🇺 Kyinsu Authorised · Novo Nordisk A/S
- 🇺🇸 Wegovy Approved · Novo
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.