Sanofi files NDA at FDA for combination of insulin glargine and lixisenatide (LixiLan), to treat type 2 diabetes

Sanofi announced that it has submitted a New Drug Application (NDA) to the FDA for its investigational fixed-ratio combination of insulin glargine 100 Units/mL and lixisenatide (LixiLan), which if approved would be administered as a single daily injection for the treatment of adults with type 2 diabetes. Sanofi redeemed a priority review voucher (PRV) with the submission to designate the NDA for an expedited 6-month review if the submission is accepted by the FDA, instead of the standard 10-month review.

This NDA submission is based on data from the LixiLan-O and LixiLan-L Phase III studies, which both reported positive top-line results earlier in 2015. These studies enrolled more than 1,900 patients worldwide to evaluate the safety and efficacy of the fixed-ratio combination when used in patient populations uncontrolled after oral antidiabetic agents (OADs) and after basal insulin therapy, respectively.

Comment: Lantus is facing biosimilar competition and LixiLan is seen as a key product for Sanofi as it defends its basal insulin franchise. If approved it will compete in the market with Novo Nordisk's insulin/GLP-1 agonist product Xultophy (insulin degludec/liraglutide), which was launched earlier this year.