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FDA accepts new drug application for novel insulin
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The manufacturer of a new basal insulin announced today that the new drug application for Toujeo — formerly known as U300 — has been accepted by the Food and Drug Administration.
This application is based upon results from the EDITION study that showed a reduced risk for hypoglycemia when comparing Toujeo (insulin glargine rDNA origin, 300U/ml) with Lantus (insulin glargine, Sanofi). The difference in reduction of HbA1c was –0.01% (95% CI, –0.14% to 0.12%), but the rate of confirmed nocturnal hypoglycemia (≤70 mg/dL) was 30.5% at 6 months in patients receiving U300 vs. 41.6% in patients taking Lantus (RR=0.73; 95% CI, 0.60-0.89).
“By reaching this key milestone in the approval process, we are pleased to take another step forward with Toujeo, an investigational new basal insulin that has been evaluated in a broad range of people living with diabetes,” Pierre Chancel, Senior Vice President, Global Diabetes at Sanofi, said in a press release. “With the FDA’s acceptance of our submission, we are anticipating the regulatory decision for marketing authorization for Toujeo in the U.S. in the first half of 2015.”
In May 2014, the European Medicines Agency accepted the marketing authorization dossier for the drug.
For more information: FDA accepts Sanofi's new drug application for basal insulin Toujeo