Sanofi’s next generation insulin shows superior profile

Sanofi’s new insulin treatment Toujeo has shown its superiority in controlling blood sugar levels in patients in phase 3 trials.

Toujeo is a new and improved formulation of Lantus (insulin glargine), which the company has refined to work for longer and more consistently once injected into the body.

Phase 3 trials showed Toujeo consistently produced significantly fewer hypoglycaemia events at any time of day, including night-time events, compared with Lantus in type 2 diabetes patients. Data from the EDITION trial programme was presented at the American Diabetes Association (ADA) meeting in San Francisco over the weekend, where Sanofi and its rivals presented their most promising pipeline treatments.

Sanofi will hope that the improvements will be enough to help it maintain its dominance in the long-acting insulin market. Lantus earned €5.72 billion ($7.7 billion) in sales last year, but loses patent protection from February 2015.

The threat from biosimilar versions of Lantus is relatively small, however, especially as Sanofi has succeeded in stalling Lilly’s biosimilar, citing patent infringements.

Sanofi faces a more pressing threat from its chief rival Novo Nordisk, which is developing its own next-generation long-acting insulin, as well as a 2-in-1 combination of its existing long-acting Tresiba and GLP-1 analogue Victoza, to be called IDegLira.

However Sanofi has breathing space before IDegLira arrives in the US, as the FDA rejected Tresiba in February last year, and an approval looks unlikely before 2017.

Sanofi has just filed Toujeo with the European Medicines Agency and has applied for regulatory approval in the US.

Geremia Bolli, Principal Investigator of the EDITION III study and Professor of Endocrinology, University of Perugia, Italy, commented: “Low blood sugar events, at any time of the day or night, should not be underestimated – particularly for those who are starting out with a new or alternate insulin therapy.”

He added: “As it is well known in clinical practice, many people go through a sensitive phase when starting insulin, and they tend to drop the treatment or not properly up-titrate when exposed to low blood sugar events. Reducing low blood sugar events in this particular phase is relevant in helping patients better manage diabetes.”



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