FDA Accepts Sanofi’s NDA for Combo Diabetes DrugBy
The US Food and Drug Administration has accepted Sanofi’s new drug application (NDA) for its investigational fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide 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.
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.