Once-Daily Insulin in Prefilled Pen Gets FDA Nod
Sanofi announced that the Food and Drug Administration (FDA) has approved once-daily Toujeo (insulin glargine [rDNA origin]) injection 300 U/mL to improve glycemic control in adults with type 1 and type 2 diabetes mellitus.
The approval of Toujeo was based on an FDA review of data from the EDITION clinical trial program that was comprised of a series of international Phase 3 studies on the safety and efficavy of Toujeo in over 3,500 adults with type 1 and type 2 diabetes. All studies met the primary study endpoints by demonstrating similar blood sugar control with once-daily Toujeo compared to once-daily Lantus (insulin glargine [rDNA origin]; Sanofi) injection 100 U/mL, including an open-label, randomized, active-control, parallel, treat-to-target studies of up to 26 weeks of duration with six months safety extension.
Toujeo will be available in the Toujeo SoloSTAR, a disposable prefilled pen with 450 units of Toujeo. It is expected to be available at the beginning of the second quarter of 2015.