Saturday , November 18 2017
Home / Resources / Articles / Diabetes Combination Drug LixiLan Meets Main Target in Late Stage Trial

Diabetes Combination Drug LixiLan Meets Main Target in Late Stage Trial

Single daily injection for type 2 diabetes is mix of lixisenatide and insulin glargine….

Sanofi’s experimental drug LixiLan is a fixed-ratio single daily injection combination of Lyxumia (lixisenatide) and Lantus (insulin glargine) for patients with type 2 diabetes. It can potentially be the first combination of basal insulin and GLP-1 agonist in a single daily injection marketed in the U.S.

According to Sanofi, LixiLan’s first late-stage phase III study has meet its main target and another will be completed at the end of the third quarter.
The results in their first study, which tested the efficacy and safety of LixiLan compared to treatment with either Lantus or Lyxumia alone, showed that LixiLan was better at reducing average blood glucose levels than either Lantus or Lyxumia. Their second study will be done to investigate LixiLan patients whose type 2 diabetes is not adequately controlled on Lantus alone.

Sanofi plans to submit LixiLan for U.S regulatory approval in the fourth quarter of 2015 and for European approval in the first quarter of 2016. Determination of their next step in regulatory process will be done according to the results from both phase III studies.

According to consensus forecasts compiled by Thomson Reuters Cortellis, LixiLan sales are expected to reach around $1 billion in 2020 and is likely to compete with Novo’s Xultophy, a combination of Tresiba and Victoza, which received European approval last year.

Practice Pearls:

  • LixiLan is single daily injection combination of lixisenatide and insulin glargine for patients with type 2 diabetes, which could possibly be the first combination basal insulin and GLP-1 agonist approved in U.S.
  • LixiLan is still in phase III studies with FDA submissions planned for late 2015.
  • Results from first study showed that LixiLan was better at reducing average blood glucose levels than Lantus or Lyxumia alone.

“Sanofi’s combination diabetes drug hits goal in late-stage trial.” Business Insider. Reuters, 29 July 2015. Web. 31 July 2015.