The Committee for Medicinal Products for Human Use (CHMP), under the European Medicines Agency (EMA), has issued a positive ruling for the use of Novo Nordisk’s Saxenda® (liraglutide 3 mg) in the treatment of obesity, according to a statement from the company.
The CHMP recommends that Saxenda® be prescribed 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). Patients also must be diagnosed with one weight-related condition such as pre-diabetes or type 2 diabetes mellitus, hypertension, or obstructive sleep apnea.
“Many people with obesity suffer from comorbidities. Saxenda® has the potential to help some of these people achieve and maintain a clinically significant weight loss and improve their weight-related comorbidities,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk in a press release. “The positive opinion from the European expert committee is an important milestone in the regulatory process for Saxenda®.”
Novo Nordisk expects to receive marketing authorization from the European Commission within two to three months. Once granted the Commission’s approval, Novo Nordisk plans to launch Saxenda® in several European markets this year.