FDA to Review Additional Data for iGlarLixi, Approval Process Extended
Zealand Pharma announced that Sanofi has submitted to the Food and Drug Administration (FDA) updated data for iGlarLixi (insulin glargine and lixisenatide) as part of its New Drug Application (NDA) for the treatment of adults with type 2 diabetes.
The FDA previously requested additional information on the pen delivery device for iGlarLixi. This amendment to the NDA has resulted in an extension of the Prescription Drug User Fee Act (PDUFA) target date by 3 months, with a decision expected in November 2016. Sanofi originally submitted the iGlarLixi NDA in December 2015 and received FDA Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) approval, with a vote of 12-2, in May 2016.
IGlarLixi is a once-daily, fixed-ratio combination of lixisenatide, a once-daily prandial GLP-1 receptor agonist, and insulin glargine (Lantus) 100 Units/mL, a long-acting basal insulin. Lixisenatide (Adlyxin) was recently approved by the FDA on July 27, 2016 for the treatment of adults with type 2 diabetes.