Novo Nordisk's obesity drug cleared in Europe

The EMA has given a green light to Novo Nordisk's obesity drug Saxenda, adding to earlier approvals in the US and Canada.

The 3mg formulation of liraglutide has been approved by the EU regulator for use alongside dieting and exercise in adults with a body mass index (BMI) of at least 30, or those with a BMI ranging from 27 to 30 who also have at least one weight-related complication such as diabetes, high blood pressure or sleep apnoea.

Saxenda is the first once-daily human glucagon-like peptide-1 (GLP-1) analogue to be licensed to treat obesity approved in Europe and will be launched in several EU countries this year.

In trials reported last year, Saxenda helped 90 percent of obese patients lose weight, compared to 65 percent with placebo, when added to a regimen of dietary restriction and exercise. The drug is a higher-dose formulation of Novo Nordisk's big-selling diabetes therapy Victoza.

Saxenda will launch into a barren market for obesity therapies in Europe, which at the moment has just one approved drug - Roche's lipase inhibitor Xenical (orlistat) - which has been on the market for some time but has never achieved anything but modest sales.

The EMA's Committee for Medicinal Products for Human Use (CHMP) declined to give its blessing to two other obesity therapies that were recently approved in the US - Eisai and Arena's Belviq (lorcaserin) and Vivus' Qsymia (phentermine/topiramate).

The panel did however back another candidate from Orexigen Therapeutics called Mysimba (bupropion and naltrexone) that is also on sale in the US (as Contrave) and is due for EU approval shortly.

None of the new crop of obesity therapies has made much headway in the market as yet, although Saxenda could make more of an impact, thanks to new clinical data suggesting it could help delay the onset of type 2 diabetes, which could have significant healthcare benefits.

Interim data from the SCALE trial reported earlier this month showed that a year's treatment of overweight and obese patients with Saxenda achieved improvements in blood glucose and blood pressure levels. That is an encouraging initial finding, although the big pay-off could come until the study completes.

Novo Nordsk's focus on the complications of obesity, rather than simply weight loss, could help take-up of Saxenda, according to analysts, some of whom have predicted sales in excess of $1 billion a year for the new product. On the other hand, others see Saxenda's premium pricing - a sizeable premium over Victoza - as a major barrier to its adoption.