Sanofi Files LixiLan For Diabetes, Gambles Expensive Priority Review Voucher

Sanofi has filed a new drug application (NDA) with the US FDA for LixiLan, its investigational fixed-ratio combination of insulin glargine (Lantus) and the GLP-1 receptor agonist lixisenatide (Lyxumia). Sanofi also revealed that it redeemed a priority review voucher (PRV) with the filing, giving the NDA an expedited 6-month review if the submission is accepted by the FDA, instead of the standard 10-month review.