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FDA Accepts New Drug Application for Basal Insulin Toujeo

Treatment provides 300 U/mL of insulin glargine

The FDA has accepted for review the new drug application (NDA) for Toujeo (insulin glargine [rDNA origin] injection), 300 U/mL, an investigational basal insulin developed by Sanofi.

The NDA for Toujeo is based on results from the EDITION clinical trial program, which is a worldwide series of phase III studies evaluating the efficacy and safety of Toujeo in more than 3,500 people from diverse diabetes populations.

In June, positive results were reported for Toujeo in a pooled analysis of three pivotal phase III trials (EDITION I, II, and III) involving a total of 2,476 subjects with type-2 diabetes.

The rate ratio (per participant-year) of night-time hypoglycemia events was significantly reduced by 31% for Toujeo compared with Lantus (insulin glargine [rDNA origin] injection, 100 U/mL, Sanofi) over the 6-month study period (rate ratio: 0.69; P = 0.0002). In addition, the rate ratio was significantly reduced (per participant-year) by 14% for hypoglycemia events at any time of the day for Toujeo compared with Lantus (rate ratio: 0.86; P = 0.0116).

In subjects with type-2 diabetes who failed to control their blood sugar levels by treatments other than insulin, the EDITION III trial (N = 878) met its primary endpoint by showing similar control of blood sugar levels (i.e., a reduction in hemoglobin A1C) from baseline between Toujeo and Lantus at 6 months (mean changes: –1.42 and –1.46, respectively; difference: 0.04%).

The proportions of subjects with severe or confirmed (defined by plasma glucose less than or equal to 70 mg/dL) nocturnal hypoglycemia events from week 9 to month 6 (a pre-specified secondary endpoint) were also similar. Over the 6-month treatment period, the incidence of any nocturnal hypoglycemia event (i.e., the percentage of subjects with one or more events) was lower with Toujeo compared with Lantus (rate ratio: 0.76), particularly during the insulin titration phase, with a 26% risk reduction in patients experiencing nocturnal hypoglycemia events with Toujeo compared with Lantus (rate ratio: 0.74) during the first 8 weeks of treatment.

In addition, there was a 25% reduction in the risk of hypoglycemia events at any time of day or night across the 6-month study period for Toujeo compared with Lantus (rate ratio: 0.75). The findings were similar between groups for adverse events, including hypersensitivity reactions (6.9% vs. 5.7%, respectively) and injection-site reactions (3.9% vs. 4.8%, respectively).

Toujeo (insulin glargine [rDNA origin] injection), 300 U/mL, was formerly known as U300. It is not currently approved or licensed anywhere in the world.

Source: Sanofi; July 8, 2014; and Sanofi; June 14, 2014.

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