Novo Nordisk files for approval of high strength liraglutide for obesity

Danish insulin giant Novo Nordisk (NOV: N) has filed separate regulatory submissions with the US Food and Drug Administration and the European Medicines Agency for a 3mg dose of liraglutide, a once-daily human GLP-1 analogue, as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with obesity, or who are overweight with co-morbidities.

Liraglutide, sold under the brand name Victoza, is currently approved and marketed at lower doses (1.2mg and 1.8mg once-daily, as well as 0.9mg in Japan) for type 2 diabetes. Victoza is not approved for weight management and should not be prescribed for this treatment. Liraglutide 3mg is not an approved treatment.

Blockbuster potential in obesity setting

Although Novo Nordisk has declined to project eventual sales of liraglutide in the obesity setting, according to a Reuters report, but said the new product would cost around $20 a day, or more than $7,000 a year, so it would take fewer than 150,000 patients to make it a $1 billion-a-year product.