Sanofi’s US marketing application for GLP-1 agonist lixisenatide has been accepted by the FDA and is the first to include cardiovascular outcomes data, according to the company.
The once-daily injectable drug has been available in Europe as Lyxumia for type 2 diabetes since 2013 but Sanofi withdrew its application to market it in the US after the FDA requested additional data on its safety.
The French company completed its cardiovascular safety study – called ELIXA – earlier this year and re-filed its application a few weeks ago. The trial found no increased risk for cardiovascular death, heart attack, stroke, unstable angina or heart failure with the drug.
“Lixisenatide is a critical element of this portfolio,” said Pierre Chancel, who heads up Sanofi’s global diabetes portfolio. “We look forward to working with the FDA during the review process with the goal of bringing lixisenatide to patients in the US.”
While approval in the US would be a boost for Sanofi’s diabetes unit – which recently lost the top spot in the market to Novo Nordisk – the diabetes market has moved on considerably in the last couple of years.
In the interim Novo Nordisk‘s rival Victoza (liraglutide) has firmly established itself at the top of the GLP-1 agonist tree, with sales of around $2bn a year.
Meanwhile, new GLP-1 agonists that require dosing just once a week – including Eli Lilly’s Trulicity (dulaglutide), GlaxoSmithKline’s Tanzeum (albiglutide) AstraZeneca’s Bydureon (exenatide) and Novo Nordisk’s semaglutide – are either on the market or progressing through the R&D pipeline.
Moreover, the type 2 diabetes market is expected to be shaken up by the publication of new data on Boehringer Ingelheim and Eli Lilly’s oral SGLT2 inhibitor Jardiance (empagliflozin), which recently became the first diabetes therapy to cut cardiovascular death in a phase III trial.
Perhaps more importantly, for Sanofi the FDA’s acceptance of the filing is a positive marker as it gears up to apply for approval of LixiLan – which combines lixisenatide with the active ingredient in its basal insulin blockbuster Lantus (insulin glargine) – late this year.
LixiLan will give the French pharma giant a product to compete with Novo Nordisk’s Xultophy (insulin degludec/lixisenatide), which was launched in Europe earlier this year.