Sanofi is preparing to file U300, an improved version of its insulin blockbuster Lantus, with regulators on both sides of the Atlantic during the first half of next year, after the drug continued to show a solid performance in late-stage trials.
Full results from the EDITION II study, presented at the International Diabetes Federation World Diabetes Congress in Melbourne, Australia, showed that U300 demonstrated similar blood sugar control but, crucially, with 23% fewer patients experiencing night-time low blood sugar compared with Lantus.
The Paris, France-based drugmaker also announced top-line data from EDITION III, which met its six-month primary endpoint of similar blood sugar level control between the two product, but, unlike EDITION I and II, failed to show a statistically-significant reduction in night-time hypoglycaemia.
Sanofi said it is "encouraged" by the data, which indicate that U300 "could be a viable treatment option for a wide range of people with type 1 and type 2 diabetes," according to the firm's senior vice president, Global Diabetes, Pierre Chancel.
“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,” added Hannele Yki-Järvinen, Professor of Medicine, University of Helsinki, Finland.
Lantus will lose its patent protection over the next couple of years, and Sanofi has high hopes it can be replaced by U300 as it has "even flatter and more prolonged profiles" than the blockbuster.
The company has also previously noted that this new formulation based on the glargine molecule "offers the benefit of a smaller volume of subcutaneous injection compared with Lantus".