New data support Novo Nordisk’s ambitions in obesity

Novo Nordisk’s bid to extend the use of its diabetes drug liraglutide into weight management has been backed by new trial data.

A 3mg daily dose of liraglutide – which is already sold as a diabetes therapy under the Victoza brand name – helped 90% of obese patients lose weight, compared to 65% with placebo, when added to a regimen of dietary restriction and exercise.

On average, people on liraglutide who completed the year-long trial SCALE lost around 9% of their starting weight, compared to 3.5% of the placebo group. The study enrolled subjects with a range of body mass index (BMI) scores but the effect of liraglutide was remarkably similar across all those enrolled, says Novo Nordisk.

The drug’s positive effects on weight were also accompanied by improvements in health-related quality of life, according to study investigator Ken Fujioka of the Scripps Clinic in California, US.

“Obesity is more than a disease of excess weight,” he said, adding that people with obesity may experience “increased physical and mental health problems, as well as a reduced quality of life.”

Novo Nordisk is already on course to secure approval for liraglutide 3mg in obesity after a US Food and Drug Administration (FDA) voted 14 to 1 in favour of approving the GLP-1 agonist in this setting in September and – if approved – says it will sell the drug as Saxenda.

Analysts have suggested that obesity could add another $1bn a year to liraglutide’s peak sales. Victoza brought in 9.42bn Danish krone ($1.58bn) in the first nine months of 2014, a rise of 12% on the same period of 2013.

If the predictions of its sales potential in obesity prove accurate, then liraglutide would eclipse the performance of other new obesity drugs introduced in the last couple of years after a hiatus of more than a decade.

Last year, Eisai and Arena’s Belviq (lorcaserin) and Vivus’ Qsymia (phentermine/topiramate) became the first new obesity drugs to be approved in the US for 13 years, but their sales performance has been lacklustre at best, bringing in just $6m and $24m respectively in 2013. Neither drug has yet been approved in Europe.

Liraglutide will also compete in the US market with Takeda/Orexigen’s Contrave (naltrexone and bupropion), which was approved by the FDA in September after a considerable delay caused by an agency request for additional cardiovascular safety data.

The label for Contrave – which includes a shopping list of safety warnings including suicidal thoughts and neuropsychiatric reactions – could also hold it back commercially, although some analysts believe it could still achieve peak sales of between $600m and $1.2bn.

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