The US Food and Drug Administration has agreed to review Sanofi’s investigational fixed-ratio combination of its basal insulin glargine (Lantus) and GLP-1 receptor agonist lixisenatide (Lyxumia) for the treatment of adults with type II diabetes.
The submission is based on data from two Phase III studies involving more than 1,900 patients, which looked at the safety and efficacy of the fixed-ratio combo when used in patients insufficiently controlled after oral antidiabetic agents and after basal insulin therapy, respectively.
Both studies met their primary endpoints and will be presented at a medical congress this year, Sanofi said.
Also of note, the French drugmaker has redeemed a priority review voucher for the submission to speed up the FDA’s evaluation, which means that a decision on the application is expected by August.
Lixisenatide was cleared in Europe in 2013 as Lyxumia to help adults with type II diabetes achieve glycaemic control in combination with oral glucose-lowering medicinal products and/or basal insulin, but the drug is still under review in the US, with a decision expected in July.