EMA’s CHMP nods positive for Novo Nordisk's Saxenda for treating obesity
Friday, January 23, 2015
Danish diabetes care giant Novo Nordisk (NOV: N) revealed yesterday that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the use of Saxenda (liraglutide 3mg) for the treatment of obesity.
Saxenda is a once-daily glucagon-like peptide-1 (GLP-1) analogue, with 97% homology to naturally occurring human GLP-1, a hormone involved in appetite regulation. At a different dose, liraglutide is the active ingredient of Novo Nordisk’s already blockbuster diabetes drug Victoza. The US Food and Drug Administration approved Saxenda last month.
SALES PROJECTIONS
Earlier in the drug’s obesity development, analysts estimated that Saxenda could produce $1 billion revenues for the obesity indication. However, Sydbank analyst Soren Hansen said last October that he expected Saxenda to generate peak worldwide sales of 13 billion Danish kroner (~$2.0 billion) in 2024.
The CHMP positive opinion recommends that Saxenda will be indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial Body Mass Index (BMI) of >=30kg/m2 (obese), or >= 27kg/m² to < 3kg/m² (overweight) in the presence of at least one weight-related co--morbidity such as dysglycemia (pre-diabetes or type 2 diabetes mellitus), hypertension, dyslipidemia or obstructive sleep apnoea.
"Many people with obesity suffer from co-morbidities. Saxenda has the potential to help some of these people achieve and maintain a clinically-significant weight loss and improve their weight-related co-morbidities," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk, adding: "The positive opinion from the European expert committee is an important milestone in the regulatory process for Saxenda."
The CHMP positive opinion is based on data from clinical trials of Saxenda, including the Phase III SCALET clinical development program, which involved more than 5,000 people with obesity (BMI >=30kg/m2), or who were overweight (BMI >=27kg/m2) with co-morbidities.
Novo Nordisk expects to receive marketing authorization from the European Commission within two to three months. Subject to the Commission's approval Novo Nordisk plans to launch Saxenda in several European markets starting in 2015.
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