Sanofi-Aventis' diabetes drug lixisenatide is at least as effective as Eli Lilly's Byetta in keeping blood sugar levels under control, according to late-stage clinical data.
The French drugmaker said that results of the GetGoal-X Phase III clinical trial showed that its once daily GLP-1 receptor agonist lixisenatide, which it licensed from Denmark's Zealand Pharma, achieved its primary goal of non-inferiority in reducing levels of HbA1c from baseline compared with Byetta (exenatide) twice-daily in patients with type II diabetes.
But, importantly, initial findings of the 639-patient study also seem to show that Sanofi's drug caused a fewer number of hypoglycaemic events in patients than Lilly's rival (2.5% vs 7.9%), which may give it a competitive edge should it ultimately gain regulatory approval.
"GetGoal-X, the first head-to-head study comparing lixisenatide with another GLP-1, demonstrates the efficacy of lixisenatide once-daily in reducing HbA1c in people with type 2 diabetes and also shows a better hypoglycemia profile,” noted Pierre Chancel, Senior Vice President, Global Diabetes, sanofi-aventis, commenting on the results.
Despite following in the footsteps of the other successful GLP-1 agonists on the market - Byetta and Novo Nordisk's Victoza (liraglutide) - lixisenatide is still expected to take a sizeable share of the market following approval, generating blockbuster sales for Sanofi, said Jefferies International analyst Peter Welford (reports Bloomberg).
Sanofi said it will present full results at a medical congress later this year.