Novo Nordisk A/S NVO announced that Saxenda (liraglutide 3mg) received marketing authorization from the European Commission (EC), for the treatment of obesity.
Given that the Committee for Medicinal Products for Human Use adopted a positive opinion on the use of Saxenda for the treatment of obesity in Jan 2015, the EC’s decision was expected.
The authorization will cover all the 28 member states in the EU. Currently, Saxenda is the first once-daily human glucagon-like peptide-1 (GLP-1) analogue approved in Europe as an adjunct to a reduced-calorie diet and increased physical activity for weight management in patients having an initial Body Mass Index (BMI) of ≥30 kg/m2 (obese) or ≥27 kg/m2 to <30 kg/m2 (overweight) and at least one weight-related comorbidity (such as dysglycemia (pre-diabetes or type II diabetes mellitus), hypertension, dyslipidemia or obstructive sleep apnea).
Novo Nordisk intends to launch Saxenda in several European countries starting 2015.
We note that Saxenda is already approved in the U.S. and Canada as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in patients suffering from obesity (BMI ≥30 kg/m2) or overweight patients (BMI ≥27 kg/m2) with at least one weight-related comorbidity.
Our Take
We are encouraged by the approval of Saxenda in the EU. We believe that the increasing prevalence of obesity across the world and its association with modern-day lifestyle provides ample opportunity for new drugs like Saxenda. According to Novo Nordisk, approximately 10% – 30% of the adult population in the EU suffers from the disease.
Moreover, given the U.S. and EU patent expiry of two drugs in Novo Nordisk’s portfolio (NovoRapid/NovoLog and NovoLog Mix/NovoMix) in 2014 and the upcoming patent expiry on Norditropin (both the U.S. and the EU in 2017), Saxenda’s European approval is an important event for the company.
Novo Nordisk carries a Zacks Rank #2 (Buy). Other well-ranked stocks in the health care sector are ANI Pharmaceuticals, Inc. ANIP, Cytokinetics, Incorporated CYTK and Horizon Pharma plc HZNP. All these stocks carry a Zacks Rank #1 (Strong Buy).
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