French-drugmaker Sanofi has revealed positive results for its long-acting insulin Toujeo (insulin glargine 300 units/mL), in a study which has compared it to Lantus (insulin glargine 100 units/mL), which lost its patent last year.
The EDITION JUNIOR study evaluated Toujeo in children and adolescents aged six-to-17-years-old who are living with type 1 diabetes (T1D).
It met its primary endpoint with comparable reductions in average blood sugar over six months with both treatments and a similar risk of low blood sugar (hypoglycaemic) events.
In addition, the percentage of participants who experienced severe hypoglycaemia and who experienced high blood sugar (hyperglycaemic) events were similar. The number of patients experiencing severe hypoglycaemia and who experienced hyperglycaemia with ketosis was numerically lower with Toujeo.
According to Sanofi, the findings from this study has lead the European Medcines Agency’s Committee for Medicinal Products for Human Use to adopt a positive opinion, recommending the expansion of the current indication for Toujeo to include the treatment of T1D in adolescents and children (six years and older).
“Across the globe, between 50 and 80% of young people living with T1D need more treatment options to help them achieve an average blood sugar level below 7.5%,” said Dietmar Berger, global head of development at Sanofi.
“By taking this step toward investigating an additional option for children and adolescents living with diabetes, we hope to provide another treatment for them and their physicians, to develop an individualised treatment plan that helps patients better manage their disease,” he added.
Sanofi needs an expanded indication for Toujeo as sales of Lantus continue to decline – in October, the pharma giant reported a fall in its third-quarter sales, driven in part by a drop in its diabetes products sales.
The company has only just begun to emerge from a difficult period marked by patent losses for big brands, particularly in its diabetes franchise.
It has continued to struggle to recoup gains in its diabetes business – not only has it been facing a decline in its insulin sales, but it also put a hold a new alliance for a SGLT1/2 drug with Lexicon, which would have targeted the T1D market.
The drug, Zynquista (sotagliflozin), was a key element in Sanofi’s plans to rebuild its diabetes franchise following the loss of patent protection for its basal insulin Lantus.