Sanofi has used an FDA priority review voucher for diabetes combination LixiLan, trying to get its nose in front in a race to market with Novo Nordisk.
The French pharma group paid $245m for the voucher – which cuts four months of the FDA’s usual review time – in a deal with Retrophin earlier this year.
Sanofi clearly sees a big benefit if it can bring LixiLan – a combination of its long-acting Lantus (insulin glargine) product and GLP-1 agonist lixisenatide – to the US market ahead of Novo Nordisk’s rival Xultophy (insulin degludec/liraglutide).
Xultophy was launched in Europe earlier this year and is currently under review by the FDA after being submitted for approval in September with a standard 10-month review time. Sanofi’s product is currently known as LixiLan in Europe and is due to be filed early next year – at the moment neither a European nor a US trade name has been selected.
With $8bn-a-year Lantus already facing biosimilar competition in some markets, LixiLan is seen as a key product for Sanofi as it defends its basal insulin franchise. In trials, the combination product met the primary objective of superior reductions in haemoglobin A1c (HbA1c) – a measure of glucose control over time – compared to Lantus alone.
“A large unmet medical need still exists for people with type 2 diabetes, as more than half are not at their blood sugar goal despite using oral medications or insulin,” commented Pierre Chancel, who heads Sanofi’s global diabetes unit.
“We recognise the need for additional treatment options and look forward to working with the FDA during their consideration of our submission,” he added.
Lixisenatide is a once-daily GLP-1 agonist that was invented by Zealand Pharma and has been sold by Sanofi as Lyxumia since 2013. In the same year, Sanofi withdrew its marketing application for the drug after it became clear the FDA would need additional data, but the firm refiled the dosser in September.