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Sanofi Submits Application for Fixed-Dose Insulin Glargine/Lixisenatide Combo
Sanofi has filed a new drug application with the FDA for the approval of an investigational fixed-dose combination of insulin glargine 100 units/mL (Lantus) and lixisenatide (Lyxumia), a glucagon-like peptide-1 (GLP-1) receptor agonist. If approved, the product would allow clinicians to treat adults with type-2 diabetes with a once-daily injection.
The FDA granted the product a priority review designation, which allows expedited review within six months rather than the usual 10 months.
The submission was based on positive data from the phase III LixiLan clinical development program, which consisted of two studies, LixiLan-O and LixiLan-L. LixiLan-O investigated the efficacy and safety of a once-daily injection of the fixed-dose combination of insulin glargine and lixisenatide in comparison with that of either lixisenatide or insulin glargine alone during 30 weeks of treatment in 1,170 patients whose type-2 diabetes had not been adequately controlled with metformin alone or with metformin combined with another oral antidiabetic agent. Treatment with metformin was continued for all participants throughout the study.
LixiLan-L, another 30-week study, evaluated the efficacy and safety of the fixed-dose combination in 736 patients whose type-2 diabetes was not adequately controlled at screening with a basal insulin, with or without oral antidiabetic drugs. If taken at baseline, metformin was continued throughout the study.
In both studies, the fixed-dose combination of insulin glargine/lixisenatide demonstrated a statistically superior reduction in hemoglobin A1c (the average blood glucose level over the previous three months) compared with lixisenatide alone and with insulin glargine alone.
A brand name for the investigational product is still being reviewed.
Sources: Sanofi; December 23, 2015; Sanofi; September 14, 2015; and Sanofi; July 29, 2015.