Sanofi’s Toujeo® receives positive opinion from European regulatory authority
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has announced a positive opinion recommending variation to the marketing authorisation of Toujeo (insulin glargine [rDNA origin] 300U/mL) for the treatment of adults with Type 1 and Type 2 diabetes in Europe.
The CHMP positive opinion was based on an assessment of the results from the EDITION clinical trial programme, which evaluated the efficacy and safety of insulin glargine 300U/mL compared to Lantus® (insulin glargine [rDNA origin] injection, 100U/mL) in over 3,500 people with diabetes. The EDITION programme demonstrated that insulin glargine 300U/mL provides equivalent glycaemic control to insulin glargine 100U/mL. In people with Type 2 diabetes, the incidence of confirmed hypoglycaemia was lower with insulin glargine 300 U/mL, in particular at night, as compared to insulin glargine 100 U/mL.
Hypoglycaemia is one of the most frequent adverse events experienced by insulin users, and fear of experiencing hypoglycaemic events prevent many patients administering appropriate insulin doses and can also lead to discontinuation of treatment.
The CHMP’s positive opinion on Toujeo will now be reviewed by the European Commission, and if accepted, the varied marketing authorisation will be applicable to the medicine within the European Union. This decision is expected to be announced in the first week of May.