Novo Nordisk's Saxenda gains EU approval for obesity

There was good news for Danish diabetes care giant Novo Nordisk (NOV: N) yesterday, when, late in the day, the company announced that it had received European marketing authorization for Saxenda (liraglutide 3mg) for the treatment of obesity.

The authorization covers all 28 European Union member states. Novo Nordisk expects to launch Saxenda in several European markets starting in 2015. Given that the approval was widely expected after a positive European Medicines Agency panel review, there was little impact on the company’s shares, which edged u just over 1% to 342.76 Danish kroner shortly after markets opened.

Saxenda, the first once-daily human glucagon-like peptide-1 (GLP-1) analogue for the treatment of obesity, is indicated in the EU 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 co-morbidity such as dysglycemia (pre-diabetes or type 2 diabetes mellitus), hypertension, dyslipidemia or obstructive sleep apnoea. At a lower dosage, liraglutide is the active ingredient of Novo Nordisk’s latest, and already blockbuster, diabetes drug Victoza, which last year generated sales of 13.43 billion Danish kroner ($1.95 billion).