Novo Nordisk’s Saxenda Receives European Regulatory Approval
Novo Nordisk has confirmed that their obesity drug, Saxenda, has received regulatory approval from the European Commission.
The announcement follows earlier regulatory approval by the EMA (European Medicines Agency) in January and by the US FDA (Food and Drug Administration) in December.
Specifically, the approval allows Saxenda to be used in patients who have an initial body mass index (BMI) of over 27 kg/m2, alongside at least one other weight-related problem – such as hypertension, dyslipidaemia or obstructive sleep apnoea. The drug is required to be used alongside a reduced-calorie diet and increased exercise.
Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk, commented that “the approval of Saxenda in the EU is an important development for people with obesity,” adding that Novo Nordisk “believe it has the potential to help some of these people achieve and maintain clinically significant weight loss and improve their weight-related comorbidities.”
Obesity is believed to affect around 10-30% of adults within Europe. Obesity is a complex disease that is influenced by genetic, physiological, environmental and psychological factors and is associated with serious health consequences and decreased life expectancy.
Novo Nordisk noted that Saxenda is the first once-daily GLP-1 analogue approved for the treatment of obesity in Europe.
Saxenda’s previous use as a diabetes treatment means that analysts have confidence in its market potential, and have predicted that it could generate $1 billion in revenue for Novo Nordisk.
The company have confirmed that they expect to launch the drug within European markets later this year.