The FDA has approved Sanofi’s once-daily basal insulin Toujeo, seen as a critical new drug for the company as it tries to maintain its position in the diabetes market.
Toujeo is a long-acting follow-up to Sanofi’s $7bn-a-year basal insulin Lantus (insulin glargine), which is starting to feel pressure from price reductions in the US as well as the threat of biosimilar competition. The new product is expected to be launched within the next few weeks, and could also be approved in the EU in the second-quarter.
Lantus and Toujeo are both administered once daily but in clinical trials the newer product was associated with equivalent blood glucose control but significantly lower levels of hypoglycaemia, particularly at night, thanks to a smoother pharmacokinetic/pharmacodynamic profile.
“The fear of hypoglycaemia is a major hurdle for patient adherence and compliance,” commented Pascale Witz, head of strategic commercial development at Sanofi, during the firm’s annual results presentation earlier this month. The low injection volume for Toujeo also makes it easier and quicker to administer, he added.
“Despite the proven efficacy of insulin, ensuring effective titration and maintenance can be a challenge for both patients and healthcare professionals due to hypoglycaemia concerns,” said diabetes specialist John Anderson of the Frist Clinic in Nashville, adding that around half of all patients living with diabetes remain uncontrolled.
Sanofi has made no secret of the fact that it will try to aggressively switch patients from Lantus to Toujeo – in fact its forecasts of parity or slight growth in its diabetes franchise this year rely on that happening.
Meanwhile, the competitive landscape for Sanofi has become a lot less complicated of late, which will give just-appointed new chief executive Olivier Brandicourt some comfort when he takes the helm in April.
Eli Lilly – via its collaboration with Boehringer Ingelheim – has long been considered main threat to Sanofi’s diabetes franchise in the next couple of years. Not only is it is developing a biosimilar version of Lantus that has been given the nod in Europe, but also has a long-acting insulin peglispro candidate that outperformed Lantus in clinical trials.
Earlier this week however, Lilly said it had delayed plans to file for approval of insulin peglispro until 2016 after worrying changes in liver fat were seen in trials, leading some analysts to conclude that the company had missed its window of opportunity.
With Novo Nordisk’s Tresiba (insulin degludec) rival also delayed in the US by a request for a cardiovascular outcomes study – Sanofi has a clearer run at establishing market share for Toujeo.
However, while a US launch for Tresiba had originally been put out to 2017, there have been suggestions latterly that the company may be able to go to the FDA with interim data from its DEVOTE outcomes trial – due later this year – which could bring that date forward by up to a year.