Novo Nordisk gets CHMP backing for obesity drug Saxenda

Novo Nordisk has won a Committee for Medicinal Products for Human Use (CHMP) endorsement for a higher-dose version of its diabetes drug liraglutide that can be used to treat obesity.

The Danish drugmaker’s new 3 mg formulation, which, when approved, will be marketed as Saxenda, has been given a positive opinion as an adjunct to a reduced-calorie diet and increased physical activity for weight management in obese adults, as well as heavily overweight people with a weight-related problem such as diabetes, high blood pressure or sleep apnoea.

In trials reported last year, Saxenda helped 90 per cent of obese patients lose weight, compared to 65 per cent with placebo, when added to a regimen of dietary restriction and exercise.

“Many people with obesity suffer from co-morbidities,” said Novo Nordisk’s chief science officer Mads Krogsgaard Thomsen, in a statement.

“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,” he added. The product has also been approved in the US and is due to be launched there in the first half of this year.

The glucagon-like peptide-1 (GLP-1) analogue is already a big earner for Novo Nordisk in a lower 1.8g formulation – Victoza – that is used to treat type 2 diabetes and achieved sales of 9.4 million Danish kroner ($1.4 billion) in the first nine months of 2014.

Sydbank analyst Soren Hansen said in a note to clients published shortly before Saxenda was approved in the US that he expected Saxenda to generate peak worldwide sales of around $2 billion in 2024.

Other analysts are more cautious, however, predicting peaks sales of $1 billion or lower and pointing to lacklustre take-up of other new obesity drugs such as Eisai and Arena’s Belviq (lorcaserin) and Vivus’ Qsymia (phentermine/topiramate), which in 2013 became the first new obesity drugs to be approved in the US for 13 years.

Saxenda will arrive on the market in Europe at around the same time as a rival obesity therapy from Orexigen Therapeutics called Mysimba (bupropion and naltrexone), which was first approved in the US as Contrave last year and was given a CHMP positive opinion last month.

At the moment the only drug for obesity on the market in Europe is Roche’s Xenical (orlistat), a lipase inhibitor that has been available for around 15 years but whose use has been somewhat limited by modest efficacy and some unpleasant side effects.

Meanwhile, neither Belviq nor Qsymia has been approved in the EU, with the EMA declining them because of safety concerns.

Saxenda is considered to have the best chance of injecting some new momentum into the obesity market, thanks to a relatively clean side-effect profile and plenty of experience with the active ingredient, although as an injectable therapy it may prove less popular with patients than some of the oral alternatives. Contrave could also be a driver but has a series of safety warnings that could limit its use.

Datamonitor analyst Daniel Chancellor said last September that he does not expect either Saxenda or Mysimba/Contrave to be revolutionary in obesity, although he expects Saxenda to make a bigger impact thanks, in part, to the “considerable overlap” between obesity and diabetes.

Novo Nordisk has not disclosed its pricing plans for Saxenda yet, although there are rumours it is considering a price of $9,000 per year, which would be a significant premium to Victoza.

Meanwhile, the company recently suggested that it intends to introduce the drug into the private market in the UK and other European countries, side-stepping reimbursement negotiations by asking patients to fund treatment out-of-pocket.

Image courtesy of Shutterstock – Umit Erdem


New data support Novo Nordisk’s ambitions in obesity

Don't miss your daily pharmaphorum news.
SUBSCRIBE free here.