Drugs Xagena
The European Commission has granted marketing authorization in Europe for Toujeo ( Insulin glargine [ rDNA origin ] injection, 300 U/mL ), a next-generation basal Insulin for the treatment of type 1 and type 2 diabetes mellitus in adults.
The European Commission's decision to grant marketing authorization in Europe for Toujeo is based on results from the EDITION clinical trial program, a series of worldwide phase III studies evaluating the efficacy and safety of Toujeo compared with Lantus ( Insulin glargine [ rDNA origin ] injection, 100 U/mL ) in more than 3,500 adults with type 1 or type 2 diabetes who were uncontrolled on their current therapy.
Blood sugar control with Toujeo was comparable to Lantus, with a favorable safety profile.
The incidence of confirmed hypoglycemia was lower with Toujeo as compared to Lantus, both at any time of the day and at night, in people with type 2 diabetes.
Toujeo has also demonstrated more stable and more predictable glycemic control and low within-individual blood sugar variability that lasted beyond 24 hours compared with Lantus in people with type 1 diabetes.
Despite basal Insulin being a cornerstone treatment for diabetes for decades, significant unmet medical needs remain a reality, with approximately half of patients on treatment not reaching their blood sugar level targets.
In addition, optimal Insulin dose is often not reached during initiation or maintenance phase.
Toujeo is a next-generation, once-daily basal Insulin based on a broadly-used molecule ( Insulin glargine ) with a well-established benefit-risk profile.
Its compact subcutaneous depot leads to more stable and more prolonged pharmacokinetic / pharmacodynamic ( PK/PD ) profiles.
Results from the EDITION clinical trials demonstrated that glycemic control with Toujeo was comparable to Lantus. The incidence of confirmed hypoglycemia ( at any time of the day and nocturnal ) was lower in patients treated with Toujeo compared to Lantus-treated patients, in patients with type 2 diabetes treated in combination with either non-Insulin anti-hyperglycemic medicinal product or mealtime Insulin.
The superiority of Toujeo over Lantus in lowering the risk of confirmed nocturnal hypoglycemia was shown in patients with type 2 diabetes treated with basal Insulin in combination with either non-Insulin anti-hyperglycemic medicinal product ( 18% risk reduction ) or mealtime insulin ( 21% risk reduction ) during the period from week 9 to end of study period.
Overall, these effects on hypoglycemia risk were consistently observed whatever the age, gender, body mass index ( BMI ) and duration of diabetes ( less than 10 years and greater than or equal to 10 years ) in Toujeo-treated patients compared Lantus-treated patients.
In patients with type 1 diabetes, the incidence of hypoglycaemia was similar in patients treated with Toujeo compared to Lantus-treated patients. ( Xagena )
Source: Sanofi, 2015
XagenaMedicine_2015
