The European Commission has approved the sale and marketing of an injectable drug developed by Novo Nordisk used for treating obesity.
In a statement, Novo Nordisk announced that the Commission has authorized it to sell Saxenda in 28 member countries of the European Union (EU), where the drug is expected to launch sometime this year. Some 10 to 30 percent of the entire adult population in Europe are considered obese.
"The approval of Saxenda in the EU is an important development for people with obesity who also suffer from weight-related comorbidities," says [pdf] Mads Krogsgaard Thomsen, executive vice president and chief science officer at Novo Nordisk. "We believe Saxenda has the potential to help some of these people achieve and maintain clinically significant weight loss and improve their weight-related comorbidities."
Saxenda is the brand name of Novo Nordisk's 3 mg formulation of liraglutide, a glucagon-like peptide-1 (GLP-1) analog that is 97 percent similar to naturally occurring GLP-1, a hormone that is triggered upon food intake and decreases weight by regulating the appetite and reducing food intake. Liraglutide is a GLP-1 receptor agonist, which reduces blood glucose by stimulating insulin and reduces glucagon secretion in a glucose-dependent manner.
The Danish drug maker says Saxenda can be used as an adjunct to a reduced-calorie diet and increased physical activity in obese adults, or adults with a body mass index (BMI) of more than 30 kg/m2, and in overweight adults who have a BMI between 27 kg/m2 and 30 kg/m2 who have at least one obesity-related disease, including pre-diabetes, type-2 diabetes, hypertension, dyslipidemia or abnormal amount of lipids in the blood, obstructive sleep apnea, and certain types of cancer.
Novo Nordisk says Saxenda was tested in the third phase of the Satiety and Clinical Adiposity-Liraglutide Evidence in Nondiabetic and Diabetic people (SCALE) trial program, which involved more than 5,000 patients who were either obese or overweight.
In December 2014, the U.S. Food and Drug Administration greenlighted Saxenda as an adjunct to diet and exercise in obese and overweight people. This was followed by the approval of the injectable by Canadian health regulators in February.
Photo: Tony Alter | Flickr