FDA Delays Approval Decision for Sanofi's Insulin Glargine, Lixisenatide Pen for Diabetes

Sanofi has submitted updated information to the FDA as part of a previously submitted New Drug Application (NDA) for its investigational once-daily, fixed-ratio combination of basal insulin glargine 100 units/mL (Lantus) and lixisenatide (Adlyxin) to treat type 2 diabetes in adults.

The FDA initially accepted the NDA for the combination back in February 2016, and its Endocrinologic and Metabolic Drugs Advisory Committee voted to approve it in May 2016. It was originally anticipated that the FDA would make an approval decision by August 2016, following Sanofi’s redemption of a Priority Review Voucher with the original submission. However, the additional information submitted on the pen delivery device at the FDA’s request now extends the drug’s Prescription Drug User Fee Act goal date by 3 months to November 2016.

The FDA approved Sanofi’s lixisenatide monotherapy in July 2016. The company originally submitted an NDA for the glucagon-like peptide 1 (GLP-1) receptor agonist in 2013, but it pulled that application because the FDA was concerned about the cardiovascular safety of similar diabetes drugs. However, the subsequent ELIXA trial successfully addressed the FDA’s request to demonstrate that lixisenatide does not increase the risk of cardiovascular adverse events.

Insulin glargine 100 units/mL has been approved since April 2000.

Sanofi’s NDA for the insulin/GLP-1 receptor agonist combination was originally submitted in December 2015. It was based on data from 2 phase 3 studies that met their primary endpoints in evaluating its safety and efficacy in more than 1900 patients insufficiently controlled after oral antidiabetic agents and after basal insulin therapy, respectively.