Sanofi submits updated iGlarLixi information to FDA

Zealand Pharma recently announced that Sanofi has submitted updated information for iGlarLixi’s pen delivery device to the U.S. Food and Drug Administration (FDA).

The submission of the information regarding iGlarLixi is part of the company’s New Drug Application (NDA) for the drug.

iGlarLixi is a once-a-day, fixed-ratio drug that is a mixture of lixisenatide and insulin glargine 100 Units/mL designed to treat type 2 diabetes in adults. The additional information submitted by Zealand was requested by the FDA and signifies a Major Amendment to the company’s NDA. The result is a three-month extension of the Prescription Drug User Fee Act.

“The extension of FDA’s review time for iGlarLixi by three months to November 2016 is related to a request for additional information on the pen device,” Zealand President and CEO Britt Meelby Jensen said. “IGlarLixi is a combination of two already FDA approved diabetes medicines and has in clinical trials demonstrated significant benefits for adults with type 2 diabetes. The combination received a convincing positive recommendation for approval by an FDA advisory committee in May, and Sanofi believes that the additional information submitted will result in an offering that will serve the patient needs.”

Zealand developed lixisenatide, which is approved and marketed globally by Sanofi outside the U.S. under the brand name Lyxumia.