Sanofi’s combination insulin/GLP-1 agonist drug iGlarLixi (formerly LixiLan) has met objectives in two phase III trials, setting up a showdown in the diabetes market.
The combination product – based on the ingredients in Sanofi’s Lantus (insulin glargine) blockbuster and recently-approved Lyxumia (lixisenatide) – was found to be more effective at controlling blood glucose in type 2 diabetics compared to either drug used alone. The results of the trials were presented at the American Diabetes Association annual meeting in New Orleans over the weekend.
The positive data comes as iGlarLixi approaches an FDA decision on approval – due in August – after a positive advisory committee vote last month. The drug is also under review in Europe with a decision due next year.
If approved it will compete directly with Novo Nordisk’s IDeglira/Xultophy (insulin degludec and liraglutide), which is already on sale in Europe and due for a US FDA decision in September. Sanofi filed its drug later than Novo Nordisk in the US but leapfrogged its rival thanks to the purchase of a priority review voucher.
The LixiLan-O trial compared the once-daily combination injection with either lixisenatide or insulin glargine over a 30-week period in type 2 diabetics whose blood sugar was not adequately controlled with metformin, with or without an additional oral antidiabetic drug.
The LixiLan-L trial had a similar design but involved type 2 diabetes patients who already require insulin injections to manage symptoms, either alone or in combination with oral antidiabetic drugs, and compared LixiLan only to insulin glargine.
In both trials, LixiLan was significant more effective than the monotherapies at reducing haemoglobin A1c (HbA1c) levels, a marker of glucose control, reducing it by around 8% versus 1-2% for the comparators.
They also showed that LixiLan was no more likely to cause low blood sugar episodes (hypoglycaemia) than insulin glargine, but predictably was a little more likely to do so than lixisenatide monotherapy.
The positive data is a boost to Sanofi’s hopes of securing US approval, given concerns raised by the FDA reviewer about the product’s dosing and delivery device and – in particular – questions about whether the data supported once-daily dosing.
Along with long-acting Lantus follow-up Toujeo, iGlarLixi is a key element in Sanofi’s plans to defend its Lantus franchise – which hit $8bn a year at peak but has started to feel the effects of biosimilar competition.