The US FDA has accepted Sanofi’s marketing application for Toujeo, the follow-up to its market-leading basal insulin Lantus.
The regulator will now spend the next few months assessing the safety and efficacy of Toujeo, formerly known as U300, which is a concentrated version of Lantus that has demonstrated an improved side effect profile compared to its predecessor.
A decision on the drug’s use in people in the US with both type 1 and type 2 diabetes is expected in the first half of 2015, according to Sanofi’s head of global diabetes, Pierre Chancel.
Sanofi will be hoping for a smoother FDA assessment than its rival Novo Nordisk’s next generation basal insulin Tresiba, approval of which has been delayed so that the manufacturer can provide more safety data.
Both Toujeo and Tresiba have demonstrated improved effectiveness and a reduced risk of hypoglycaemia over their respective precursors and Sanofi is banking on its insulin matching the success of Lantus, which made more than $7bn in 2013.
Chancel previously confirmed to PMLiVE that Sanofi was looking to market Toujeo as a direct alternative to Lantus at a price that was affordable for healthcare systems.
“Is it going to replace Lantus? Yes,” he said at the American Diabetes Association meeting last month. “Are we going to look for quick access? Yes. Are we going to push for switch? Yes.”
These ambitions could be hampered by the prospect of cheaper biosimilar versions of Lantus, which are due to launch once its patents expire over the next few years.
Leading the way is the diabetes collaboration between Lilly and Boehringer Ingelheim, which had its biosimilar insulin glargine Abasria recommended in the most recent round of opinions from the European Medicines Agency (EMA).
The EMA is also currently assessing Toujeo after accepting it for review in May this year.