The approval paves the way for Sanofi's insulin and GLP-1 combination therapy, which is due for final FDA action in August.
FDA has approved lixisenatide, the GLP-1 receptor agonist that was the first diabetes therapy submitted to regulators with full cardiovascular safety results in hand.
Sanofi, which plans to market the drug as Adlyxin, announced the approval Wednesday. The therapy has been sold as Lyxumia in more than 60 countries, including most of Europe, as well as Mexico and India, which have high rates of diabetes.
Lixisenatide is given at mealtime once daily by injection with a prefilled pen. Patients take a 10 mcg dose for 2 weeks before moving to a 20 mcg dose. This phased-in dosing is designed to limit nausea, which can be a side effect of GLP-1 receptor agonists as patients adjust to the therapy.
The drug blocks the effect of glucagon-like peptide (GLP-1) on pancreatic cells that, when functioning normally, regulate insulin secretion. Lixisenatide boosts glucose-dependent insulin secretion.
Approval was based on clinical results from Sanofi’s GetGoal program, as well as CV results from the ELIXA trial presented at the June 2015 meeting of the American Diabetes Association (ADA) in Boston. Sanofi provided FDA with results from 11 multinational trials that showed lixisenatide reduced glycated hemoglobin (A1C) from 0.7% to 1.0% and, after 24 weeks, allows more patients to bring A1C below 7.0% than placebo. ELIXA found that lixisenatide was safe, with no CV benefits but no harmful effects, either.
The action gives Sanofi approval of both components of its GLP-1 and insulin combination therapy, which received a recommendation from an FDA advisory panel in late May. Full results for the therapy, which pairs lixisenatide with Sanofi’s mainstay insulin, Lantus, were presented at the 2016 ADA meeting in New Orleans. The combination met its primary endpoints in phase 3 trials, and Julio Rosenstock, MD, presented findings that show the combination performs better than the sum of its parts.
An FDA decision on the combination is due in August, while a decision on a competing insulin / GLP-1 combination from Novo Nordisk is expected by September.