Sanofi’s combination therapy Suliqua has been granted European marketing approval for the treatment of adults with type 2 diabetes.
The dual-drug treatment combines the firm’s blockbuster Lantus (insulin glargine) and with Lyxumia (lixisenatide) and aims to improve glycaemic control for those where metformin alone or in combination is not sufficient.
Approval of the once-daily injection was based on two phase III studies – LixiLan-O and LixiLan-L – which showed Suliqua to be statistically superior in reducing blood sugar levels in comparison with both Lyxumia and Lantus.
Dr Elias Zerhouni, president of global R&D at Sanofi, said: “Suliqua is an innovative new combination therapy that has the potential to address significant unmet needs for people living with type 2 diabetes in Europe.
“The approval of Suliqua represents the successful culmination of a concerted effort by Sanofi scientists to bring two injectable treatments together in a single and precisely titratable dose.
“Sanofi has a long history of elevating care for people with diabetes, and we believe Suliqua will make it easier for patients with inadequately controlled diabetes to reach their treatment goals.”
The long-acting basal insulin and GLP-1 agonist is already on the market in the US as Soliqua, having been approved by the FDA in November last year on the same day as rival therapy Xultophy, Novo Nordisk’s insulin degludec and liraglutide combination.
In the EU, however, Xultophy has the edge as it received regulatory approval in 2014 in Europe, where it is marketed as IDegLira.
Both companies are vying for market share in the sector, but analysts have predicted Xultophy will take the lead with sales of $1.2bn by 2021 in comparison with the $550m forecast for Suliqua.