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Saxenda (liraglutide)

Region

🇪🇺 EU

Active substance

liraglutide

Company

Novo Nordisk A/S

Status

Authorised

Therapeutic area

Obesity; Overweight

CHMP opinion

Thu 22 Jan 2015

EU approval

Mon 23 Mar 2015

Application

EMEA/H/C/003780

ATC

A10BJ02

Official record

www.ema.europa.eu

Indication

Saxenda is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial Body Mass Index (BMI) of • ≥ 30 kg/m² (obese), or• ≥ 27 kg/m² to < 30 kg/m² (overweight) in the presence of at least one weight-related comorbidity such as dysglycaemia (pre-diabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia or obstructive sleep apnoea. Treatment with Saxenda should be discontinued after 12 weeks on the 3.0 mg/day dose if patients have not lost at least 5% of their initial body weight. Adolescents (≥12 years) Saxenda can be used as an adjunct to a healthy nutrition and increased physical activity for weight management in adolescent patients from the age of 12 years and above with: obesity (BMI corresponding to ≥30 kg/m2 for adults by international cut-off points)* and body weight above 60 kg. Treatment with Saxenda should be discontinued and re-evaluated if patients have not lost at least 4% of their BMI or BMI z score after 12 weeks on the 3.0 mg/day or maximum tolerated dose. *IOTF BMI cut-off points for obesity by sex between 12-18 years, in accordance with study design of the Trial 4180, see section 5.1. Children (6 to <12 years)Saxenda is indicated as an adjunct to healthy nutrition and increased physical activity for weight management in children from the age of 6 to <12 years with&nbsp;- obesity (BMI ≥95th percentile)* and- body weight ≥45 kgTreatment with Saxenda should be discontinued and re-evaluated if patients have not lost at least 4% of their BMI or BMI z score after 12 weeks on the 3.0 mg/day or maximum tolerated dose. *CDC BMI cut-off points for obesity (≥95th percentile) by sex between 6 to <12 years, in accordance with study design of the Trial 4392, see section 5.1.

Regulatory milestones

No milestones recorded in the last year.

Same substance in other markets

• 🇪🇺 Ablymico Authorised · STADA Arzneimittel AG
• 🇪🇺 Liraglutide STADA Authorised · STADA Arzneimittel AG
• 🇪🇺 Victoza Authorised · Novo Nordisk A/S
• 🇪🇺 Xultophy Authorised · Novo Nordisk A/S

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.