FDA accepts filing of fixed-ratio lixisenatide + basal insulin glargine (LixiLan) to treat type 2 diabetes-Sanofi

Sanofi announced that the FDA has accepted the New Drug Application (NDA) for its investigational fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide (provisionally called LixiLan) for the treatment of adults with type 2 diabetes. Following the redemption of a Priority Review Voucher with the submission, an FDA decision is anticipated in August 2016.

This NDA submission is based on data from two Phase III studies, which enrolled more than 1,900 patients worldwide to evaluate the safety and efficacy of the fixed-ratio combination when used in patient populations insufficiently controlled after oral antidiabetic agents (OADs) and after basal insulin therapy, respectively. Both studies met their primary endpoints and will be presented at a medical congress in 2016. The safety and efficacy of the fixed-ratio combination have not been evaluated by any regulatory authority, and the proprietary name is under consideration. Preparations are on track for regulatory submission in the European Union in March 2016.

The investigational GLP-1 receptor agonist lixisenatide was evaluated in patients with type 2 diabetes and is also currently under review by the FDA. The NDA for lixisenatide was accepted in September 2015, and an FDA decision is anticipated in July 2016.

Comment: Lantus (basal insulin glargine) is already 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.