Sanofi’s diabetes drug Toujeo approved in Europe

Sanofi’s follow-up product to its insulin blockbuster Lantus has been approved in Europe.

Toujeo (insulin glargine [rDNA origin]) has been approved for the treatment of type 1 and type 2 diabetes mellitus in adults.

The drug is a modified version of Lantus, the company’s biggest selling product, which earned €6.34 billion ($7 billion) last year, but now faces increasing competition.

Toujeo was approved based on Sanofi’s EDITION trial programme, which compared it with Lantus, and follows US FDA clearance in February.

The studies found blood sugar control with Toujeo was comparable to Lantus, with an improved safety profile. The incidence of confirmed hypoglycaemia was lower with Toujeo compared to Lantus, both at any time of the day and at night, in people with type 2 diabetes. Toujeo also demonstrated more stable and more predictable glycaemic control and low within-individual blood sugar variability that lasted beyond 24 hours compared with Lantus in people with type 1 diabetes.

Sanofi’s new chief executive Olivier Brandicourt must now ensure his company can persuade doctors that this data on hypoglycaemia reduction is a compelling reason to switch from Lantus, which is facing competition from biosimilars – including Lilly/Boehringer Ingelheim’s Abasria, which won CHMP backing last September.

Another rival is Novo Nordisk’s ultra-long-acting insulin Tresiba, which has been on the market in Europe since 2013. Tresiba has been refused US approval because of cardiovascular concerns, but looks set to finally gain FDA clearance later this year.

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