Novo’s Saxenda label to include cardio data

European regulators have recommended an update to the label of Novo Nordisk’s weight loss drug, Saxenda, to include information about the active ingredient’s ability to reduce cardiovascular risk.

Saxenda has not been investigated for its cardiovascular risk. But the diabetes drug Victoza contains the same active ingredient, liraglutide, at a lower dose and has been shown to reduce the risk of cardiovascular death, non-fatal heart attack, and non-fatal stroke by 13% versus placebo.

Results of the LEADER trial showed a statistically significant 22% reduction in cardiovascular death and non-significant reductions in heart attacks and strokes.

Following the recommendation from Europe’s top regulatory committee, the CHMP, Saxenda’s label has been updated to reflect the primary outcome of LEADER.

Saxenda has got off to a good start since its launch in 2015, recording sales of 1.6 billion Danish kroner, (around £180 million) for the full year of 2016.

But Novo has always said that it expected Saxenda to be a slow-burner in terms of sales growth, and the cardio data could encourage doctors to prescribe it.

The data will also help Novo Nordisk differentiate itself from competitors – Orexigen markets a rival weight-loss drug, Mysimba (naltrexone+bupriopion) in Europe, and GlaxoSmithKline’s Alli (orlistat) is available over the counter.

EU regulators are reviewing a separate filing to include the cardiovascular outcomes data from LEADER in the product information of Victoza.

Novo Nordisk said it expects feedback from the EMA on the Victoza application shortly.

Mads Krogsgaard Thomsen, Novo Nordisk’s chief scientific officer, said: "The LEADER trial showed that liraglutide is associated with significant cardiovascular risk reduction in people type 2 diabetes. This is an important development for people with obesity in Europe living with weight-related comorbidities such as cardiovascular disease."

Liraglutide is a once-daily glucagon-like peptide-1 (GLP-1) analogue with 97% similarity to naturally occurring human GLP-1, a hormone that is released in response to food intake.

Like human GLP-1, liraglutide regulates appetite by increasing feelings of fullness and satiety, while lowering feelings of hunger and prospective food consumption, thereby leading to reduced food intake.