The European Commission has granted marketing authorization in Europe for Sanofi's 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 EU marketing authorization for Toujeo represents a significant milestone for Sanofi, expanding our integrated portfolio of solutions for people with diabetes in Europe," commented Pierre Chancel, senior vice-president, Global Diabetes, Sanofi. "Toujeo gives people with diabetes and their physicians a new option to manage their condition, and also reinforces our commitment to continue improving the quality of diabetes care."
The European Commission's decision to grant marketing authorization in Europe for Toujeo is based on results from the EDITION clinical trial programme, 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 favourable 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 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.
"Many people living with diabetes and requiring insulin are still not achieving adequate blood sugar control," said professor Robert Ritzel, head of the Clinic of Endocrinology, Diabetology and Addiction Medicine, Klinikum Schwabing, Städtisches Klinikum München GmbH, Munich, Germany.
"By providing glycemic stability and less variability, as well as reducing hypoglycemic events in people with type 2 diabetes, Toujeo provides a new way to address these unmet needs."
Marketing authorization in Europe for Toujeo is applicable to the 28 member states of the European Union, as well as Iceland, Lichtenstein and Norway, and follows the February 26, 2015 positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). Toujeo has been approved by the US Food and Drug Administration (FDA) and is under review by other regulatory authorities around the world.
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 per cent risk reduction) or mealtime insulin (21 per cent 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, BMI and duration of diabetes (<10 years and >=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.