Friday, January 23, 2015
Just one month after the GLP-1 analogue liraglutide 3 mg received approval for obesity treatment by the US-FDA, liraglutide 3 mg, yesterday, also got a positive nod from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA).
Here is how the Novo Nordisk press release describes the mode of action and indication for liraglutide 3 mg:
“Saxenda®, the intended brand name of liraglutide 3 mg, 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. 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 >=30 kg/m2 (obese), or >= 27 kg/m² to < 30 kg/m² (overweight) in the presence of at least one weight-related comorbidity such as dysglycaemia (pre-diabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia or obstructive sleep apnoea.”
Regular readers will be aware of the role that the incretin GLP-1 plays in the regulation of glucose metabolism as well as satiety and appetite.
Data for this approval come from the Phase 3 SCALE trial program involving over 5,000 patients with overweight and obesity, the majority of who also had related comorbidities.
Given that this is an injectable drug that will be available only with a doctor’s prescription and, as any anti-obesity medication, will need to be used in the long-term, it will be interesting to see how this new approach to obesity treatment will be accepted by doctors and their patients.
Although liraglutide 3 mg may not work for or be tolerated by everyone, I am confident that this much-needed addition to the obesity treatment tool-box will provide a new treatment option to some patients – especially those with obesity related health problems.
Disclaimer: I have received honoraria for consulting and speaking from Novo Nordisk