Novo Nordisk continued to advance its diabetes portfolio, filing for EU approval of Ideglira – a combination of its insulin degludec Tresiba and its GLP-1 analogue Victoza.
The Danish pharma company said that the submission to the European Medicines Agency (EMA) covers Ideglira’s use in the treatment of type 2 diabetes.
Victoza (liraglutide) was granted EU approval in 2009 as a subcutaneous injection to treat people with type 2 diabetes, who are unable to control their blood sugar levels on other diabetes medicines, such as metformin, sulphonylurea and thiazolidinediones.
It has since gone on to become Novo’s most successful non-insulin product, achieving sales of more than €1.2bn during 2012, and growth is set to continue.
Tresiba has had less of a chance to make an impact, with Novo launching the insulin earlier this year in Europe to treat patients with both type 1 and type 2 diabetes.
It’s yet to be seen whether Novo has made a dent in Sanofi’s dominance of the long-acting basal insulin market with its insulin glargine Lantus, although the more flexible dosing schedule and reduced risk of hypoglycaemia of Tresiba have sparked interest in some healthcare commentators.
The US FDA’s refusal to back Tresiba at the beginning of this year was a major blow for Novo’s ambitions, however, although the Ideglira submission has put some wind back in the company’s sails.
The filing is based on results from the DUAL clinical trial programmes, which involved around 2,000 people with type 2 diabetes, as well as studies involving individual Tresiba and Victoza.
According to Novo, people in this study treated once-daily with Ideglira achieved an average reduction in HbA1c (a measurement of blood sugar levels) of 1.9 per cent.
In addition, 81 per cent of people previously treated with oral diabetes medicines and 60 per cent of those previously treated with basal insulin achieved the target of HbA1c of 7 per cent.
“Ideglira has the potential to become a breakthrough in type 2 diabetes treatment and we look forward to making the first combination product of insulin and GLP-1 available to people with type 2 diabetes in the EU”, said Mads Krogsgaard Thomsen, executive VP and chief science officer of Novo.
The announcement was the second major regulatory development for Victoza this month, following the news that Novo intends to file its active ingredient liraglutide for approval in the treatment of obesity.
The company said regulatory filings in the EU and US are expected to begin by the start of 2014 based on phase III results that demonstrate liraglutide can reduce a person’s weight by 8 per cent over a 56-week period.