Novo Nordisk has announced phase III trial results that put it on track to file its diabetes medicine liraglutide in a new obesity indication.
The GLP-1 agonist liraglutide is already available as an injection under the brand name Victoza to control blood sugar levels in adult patients with type 2 diabetes, but Novo is looking to compete in another therapy area by launching the drug to aid weight loss in people with obesity.
Regulatory filings in the EU and US are expected to begin by the start of 2014, according to the Denmark-based pharma company, and they will be backed by the latest phase III results that demonstrate liraglutide can reduce a person’s weight by 8 per cent over a 56-week period.
This compared to just 2 per cent for the arm of the trial treated with placebo.
The trial, which involved 3,731 overweight or obese people, also demonstrated the proportion of people achieving a weight loss of at least 5 per cent was 64 per cent for liraglutide and 27 per cent for placebo.
All trial participants in both arms took part in exercise and dietary improvements in addition to taking their medicine.
“All differences between liraglutide and placebo were statistically significantly different and the trial met all three co-primary endpoints,” said Novo.
There is still a long way to go before liraglutide reaches the market, however, and Novo should expect a tough regulatory challenge if the fate of recent obesity treatments Qsymia/ Qsiva (phentermine/topiramate) from Vivus and Belviq (lorcaserin) from Arena is anything to go by.
Vivus’ drug was approved under the brand name Qsymia in the US last year after being initially being declined in 2010 due to the potential for dangerous side effects, including birth defects.
Since its launch, it has failed to make an impact in the US, however, with Vivus reporting sales of a little more than $4m for Qsymia in the first quarter of 2013.
The story in Europe is even more disappointing for Vivus. Regulators first declined to recommend the company’s marketing application in October 2012 and then stuck to its decision in February 2013 following an appeal.
Meanwhile, Arena was only given permission to launch Belviq in the US this month – 10 months after its approval from the FDA – when the Drug Enforcement Administration (DEA) determined the level of abuse risk for the drug was satisfactory.
The company also withdrew its marketing application in the EU after regulators requested more data about the drug’s safety.
Analysts have questioned whether trial data for Novo’s liraglutide will be strong enough to overcome the regulatory challenge faced by its rivals in obesity – as well as subsequent battles for reimbursement – but these are Novo’s strongest results yet for the drug in this indication and the company is confident of liraglutide’s potential beyond diabetes.
“These data, together with previously reported phase III trials, consistently demonstrate clinically significant weight loss and improvements in obesity-related risk factors in people with obesity,” said Mads Krogsgaard Thomsen, executive VP and chief science officer of Novo.