Sanofi says it intends to file for approval of its combination diabetes drug LixiLan before the end of the year in the US after meeting its objectives in a second phase III trial.
LixiLan is a combination of insulin glargine – the active ingredient in Sanofi’s basal insulin blockbuster Lantus – and GLP-1 receptor agonist lixisenatide which is on the market in Europe and elsewhere as Lyxumia and was recently re-submitted for approval in the US. European filings for the new combination product are scheduled for early 2016, says Sanofi.
With Lantus already facing biosimilar competition, LixiLan is seen as a key product for Sanofi as it defends its basal insulin franchise. If approved it will compete in the market with Novo Nordisk’s insulin/GLP-1 agonist product Xultophy (insulin degludec/liraglutide), which was launched earlier this year.
The new phase III trial showed that LixiLan met the primary objective of superior reductions in haemoglobin A1c (HbA1c) – a measure of glucose control over time – compared to Lantus alone. The trial also compared LixiLan to Lantus plus metformin but at the moment data from that arm are not available.
“The result highlights that this could provide a treatment option for the roughly 50% of patients who are no longer able to remain at their HbA1c target, despite basal insulin treatment,” said Richard Bergenstal of the International Diabetes Center at Park Nicollet in Minneapolis, US.
With Lantus $8bn in annual revenues now under assault, Sanofi needs LixiLan and recently-launched Lantus follow-up Toujeo to perform well and analysts seem to believe that can happen, with Jefferies’ Peter Wellford indicating earlier this year that the basal insulin/GLP-1 agonists could herald a ‘paradigm shift’ in the treatment of type 2 diabetes.
There is an interesting symmetry to the face-off with Novo Nordisk, which recently displaced Sanofi as the world’s top diabetes company.
Sanofi’s product featuring the world’s biggest-selling basal insulin while Novo Nordisk’s drug incorporates the top-selling GLP-1 agonist Victoza. Similarly, while Sanofi’s lixisenatide was delayed in the US by an FDA request for a cardiovascular safety study, Novo Nordisk’s insulin degludec – sold as Tresiba – was rejected by the FDA in 2013 and was refiled earlier this year, with a decision due next month.
Both drugs have tipped to become $1bn-plus products, depending on securing approval in the important US market.