Sanofi’s next-generation insulin drug Toujeo has launched in the UK.

The drug is being touted as a successor to the company’s aging diabetes treatment Lantus (insulin glargine 100 units/mL), which has seen blockbuster sales but lost its patent protection in February 2015.

Toujeo’s (insulin glargine [rDNA origin] 300 units/mL) main advantage over Lantus is its reduction in incidences of hypoglycaemia – when blood sugar falls below a normal level. This was demonstrated in the EDITION clinical programme, where Toujeo was shown to provide non-inferior glycaemic control compared to Lantus, while reducing the incidence of hypoglycaemia in adults with type 2 diabetes.

“Two thirds of patients using insulin are failing to achieve the NICE target for blood glucose control, leaving them at risk of potentially avoidable complications such as amputation, blindness and renal disease,” David Williams, medical director for Sanofi UK, explained to PharmaTimes. “We also know the UK has the highest blood glucose threshold for insulin initiation compared to comparable countries and that hypoglycaemia has been cited by doctors as a concern if treating more aggressively.”

Melanie Davies, professor of diabetes medicine at the University of Leicester, adds: “This new basal insulin is an additional treatment option for doctors to help manage patients who are not currently able to reach optimal glycaemic control.

“Hypoglycaemia is one of the most frequent adverse events experienced by people treated with insulin and fear of these events can prevent some patients administering appropriate insulin doses and can even lead to discontinuation of treatment.”

US difficulties

In the US, however, the FDA did not acknowledge that the drug led to fewer cases of overnight hypoglycaemia in its approval ruling. Sanofi is therefore unable to market the drug with this claim in the country, making it harder to differentiate it from Lantus.

It is too early to tell whether this will have an effect on the drug’s sales in the US, but Berstein analyst Tim Anderson called its initial, first-half 2015 sales of €20 million ‘underwhelming’.

Although he was unable to comment on Sanofi’s strategy for the drug, Williams said that the company anticipates that Toujeo will generate a “significant share” of their UK insulin glargine sales within three yeas of launch.