Novo Nordisk's Saxenda cleared in Europe for the treatment of obesity

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By: Joe Barber

Ref: Avisen.dk, NASDAQ, Novo Nordisk

Published: 03/23/2015

Novo Nordisk's Saxenda cleared in Europe for the treatment of obesity
Novo Nordisk announced Monday that the European Commission granted marketing authorisation to Saxenda (liraglutide) for the treatment of obesity. Specifically, the therapy was approved for use in adults with a body mass index (BMI) of at least 30, or those with a BMI ranging from 27 to 30 who also have at least one weight-related co-morbidity. The drugmaker stated that the therapy, which is the "first once-daily human glucagon-like peptide-1 (GLP-1) analogue for the treatment of obesity approved in Europe", will be launched in several European countries this year.

In January, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending approval of the GLP-1 analogue, which is also approved for the treatment of type 2 diabetes under the name Victoza.

In the SCALE Obesity and Prediabetes study, Saxenda was found to reduce weight in obese or overweight patients without diabetes by an average of 8 percent after 56 weeks of treatment, versus a 2.6 percent reduction for placebo. Moreover, SCALE Diabetes study showed that the drug was associated with significantly greater weight loss than placebo in obese or overweight adults with type 2 diabetes.

Saxenda has been approved by regulators in the US in December last year, and in Canada last month for the treatment of chronic weight management.