US regulators have agreed to review Sanofi’s application to market once-daily prandial GLP-1 receptor agonist lixisenatide for the treatment of adults with type II diabetes.
The application is based on data from the 5,000-patient-plus GetGoal clinical programme, including that showing that the once-daily shot worked as well as twice-daily exentide (Lilly’s Byetta) in lowering blood sugar levels with a similar safety profile. But it is also the first for a GLP-1 receptor agonist to include cardiovascular outcomes data, garnered from the recently-completed ELIXA study involving more than 6,000 type II diabetics with a high CV risk.
Sanofi had intended to file lixisenatide in the US back in 2013, but pulled back the application on concerns that potential public disclosure of early interim data from the ELIXA trial, even with safeguards, could compromise the integrity of the ongoing study.
Lixisenatide was cleared in Europe in 2013 as Lyxumia to help adults with type II diabetes achieve glycemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, failed to maintain acceptable levels. The drug is now approved in over 60 countries worldwide.
Settles patent dispute with Lilly
Meanwhile, Sanofi and Lilly have laid to rest a global patent battle relating to the French drugmaker’s Lantus SoloSTAR (insulin glargine).
Lilly was seeking regulatory approval for a product which Sanofi argued would infringe on its intellectual property for Lantus SoloSTAR, but the firms have now come to an arrangement that settles all related lawsuits.
Most of the terms were kept under wraps, but the firms did say that, under the agreement, Lilly will pay royalties to Sanofi in exchange for a license to certain Sanofi patents, but will not sell its insulin glargine product before December 15 next year.