Sanofi sees PDUFA delay for iGlarLixi following data submission on pen delivery device

French pharma major Sanofi (Euronext: SAN) says it has submitted updated information on the pen delivery device as part of the New Drug Application (NDA) for iGlarLixi, 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, to the USA Food and Drug Administration.

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 late November 2016. The previous PDUFA date was August 23.

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 USA. The company says it looks forward to hearing from the FDA once the review of the updated information has been completed.

Denmark’s Zealand Pharma (Nasdaq Copenhagen: ZEAL) invented lixisenatide, a once-daily prandial GLP-1 receptor agonist, for the treatment of type 2 diabetes and granted global development and commercial rights to the product, including for use in combinations, to Sanofi. On July 27, 2016, lixisenatide was approved by the US FDA under the brand name Adlyxin for the treatment of adults with type 2 diabetes. Lixisenatide is approved and marketed globally by Sanofi outside the USA under the brand name Lyxumia.