Sanofi’s preparations for the patent expiry of blockbuster insulin Lantus remained on course with positive phase III data for its successor U300.
According to the French company, the next-generation insulin glargine demonstrated similar blood sugar control to Lantus but with 23 per cent fewer patients experiencing night-time low blood sugar – a side effect of insulin use.
The data was from the EDITION II trial, results of which were presented today at the International Diabetes Federation 2013 World Diabetes Congress in Melbourne, Australia.
The study involved 811 patients with type 2 diabetes who failed to control their blood sugar levels on current basal insulin and an oral medication. They were randomised to take either U300 or Lantus alongside oral anti-diabetic drugs, with results taken over a six-month period.
By demonstrating equivalent efficacy with reduced side effects, the study backs previous trial results presented at the American Diabetes Association meeting in June this year.
One of the EDITION II study’s lead investigators Prof Hannele Yki-Järvinen, professor of medicine, University of Helsinki, Finland, commented on the benefits U300 would bring for diabetes patients.
She said: “Reducing the risk of hypoglycaemic events is imperative for effective management of diabetes, and EDITION II suggests that U300 reduces the risk of these events, even in a challenging patient population who have been on high basal insulin doses and oral medications without being able to achieve their treatment targets.”
Sanofi also presented top-line data from the EDITION III study involving type 2 diabetes patients who had not previously used insulin and the EDITION IV and EDITION JP I study, both involving patients with type 1 diabetes.
According to Sanofi, all studies met their primary endpoints, demonstrating that U300 has similar efficacy as Lantus. Full results from these trials are to be presented in the first half of next year, which is also the planned period for Sanofi to submit marketing applications for U300 in the US and EU.
The results are important for Sanofi as current gold standard basal insulin Lantus is due to lose patient protection in late 2014, when cheaper biosimilar versions are expected to hit the market.
This includes a biosimilar insulin from Lilly and Boehringer Ingelheim, which is current under review by the European Medicines Agency (EMA).
Sanofi is also facing competition from Novo Nordisk’s next-generation insulin Tresiba, which was approved in Europe earlier this year although its approval in the US has been delayed as the FDA has demanded extra safety data.