Advisors to the European Medicines Agency have voted to support approval of Novo Nordisk’s obesity drug Saxenda, a higher dose form of its diabetes blockbuster Victoza.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Saxenda (liraglutide 3mg) as an adjunct to a reduced-calorie diet and increased physical activity for adults with a body mass index of 30 and above, or 27 in those with at least one weight-related condition such as hypertension or type 2 diabetes.
The effectiveness of Saxenda was shown in five trials involving around 5,800 obese or overweight patients, which showed that more of them achieved clinically relevant weight loss than those treated with placebo. All patients enrolled in these trials received counselling on diet and physical activity.
The CHMP recommends that patients started on Saxenda should be evaluated after 12 weeks of treatment and if they have not lost at least 5% of their initial body weight by this time, treatment should be stopped.
Mads Krogsgaard Thomsen, Novo’s chief science officer, said Saxenda “has the potential to help some of these people achieve and maintain a clinically significant weight loss and improve their weight-related comorbidities”.
Having got the thumbs-up in the USA at the end of December, Novo expects full approval in Europe within two to three months and will launch in several markets this year. The company caused a stir last year when it revealed to PharmaTimes that the UK will most probably see a private market launch; it will not to ask for reimbursement in other EU countries either.