Cardiovascular study sets Sanofi on course to refile Lyxumia

Sanofi's diabetes therapy Lyxumia has been given a clean bill of health in a cardiovascular outcomes trial, opening the door for the company to file the drug for approval in the US later this year.

The French drugmaker withdrew its marketing application for Lyxumia (lixisenatide) in the US in 2013 after deciding it needed additional data to support the drug's cardiovascular safety, in light of a tougher stance on diabetes drugs at the US FDA.

The GLP-1 analogue - which is already on the market in Europe - was shown in the ELIXA study to be non-inferior to placebo on cardiovascular risk. It was no more likely than control to cause a non-fatal heart attack or stroke, cardiovascular death or hospitalisation or hospitalisation for unstable angina, according to the results.

Sanofi's head of R&D Elias Zerhouni said lixisenatide is the first GLP-1 analogue to have data on its cardiovascular safety in patients with type 2 diabetes and an elevated level of cardiovascular risk, adding that the company now plans to file a new dossier for the drug in the US in the third quarter.

The delay in securing US approval has meant that Lyxumia is lagging behind its rivals in the GLP1 agonist sector, particularly market leader Victoza (liraglutide) from Novo Nordisk which racked up sales of nearly $2 billion last year.

In contrast, Sanofi booked sales of €27 million ($29 million) for Lyxumia last year, with the product also lagging behind other drugs in the GLP1 class including AstraZeneca's Byetta (exenatide) and long-acting follow-up Bydureon, and Eli Lilly's Trulicity (dulaglutide).

The endorsement of lixisenatide's safety will help the drug play catch-up with its rivals, but arguably more importantly also gives Sanofi a lift ahead of data - due later this year - on potential blockbuster LixiLan, which combines the GLP1 agonist with the basal insulin found in the company's big-selling basal insulin Lantus.

The combination product could help Sanofi mitigate some of the impact following the loss of patent protection for Lantus, which pulled in almost $7 billion in sales last year but is facing biosimilar competition from the likes of Lilly/Boehringer Ingelheim, whose Abasria has already been approved in some markets.

Sanofi is also hoping its next-generation long-acting insulin Toujeo will also help make up some of the shortfall from increasing competition to Lantus.