Paris, France – August 19, 2016 – Sanofi announced today that it has submitted updated information on the pen delivery device as part of the New Drug Application (NDA) for the investigational once-daily 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. The additional information, submitted at FDA’s request, constitutes a Major Amendment to the NDA, resulting in an extension of the Prescription Drug User Fee Act (PDUFA) goal date by three months, to November 2016.
Sanofi appreciates the feedback from the FDA on the delivery device and believes that the information submitted will result in an offering that will serve the needs of adults living with type 2 diabetes in the US. The company looks forward to hearing from the FDA once the review of the updated information has been completed.
On May 25, 2016, the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the FDA recommended, by a vote of 12 to 2, the approval of the NDA for the fixed-ratio combination.