Sanofi's ($SNY) combination of a Type 2 diabetes treatment and a long-acting insulin met its main goal in a Phase III trial, the company said, setting up an FDA application later this year.
Called LixiLan, the once-a-day treatment combines lixisenatide, which boosts the hormone GLP-1, with Lantus, Sanofi's top-selling insulin. In a Phase III trial on more than 1,000 patients, LixiLan met its primary endpoint by reducing average blood glucose at a statistically superior rate than its composite parts alone, Sanofi said, charting a similar safety profile in the process. The company is disclosing only top-line results for now, saving full data for a later medical meeting.
Now Sanofi is working to wrap up a second Phase III study, comparing LixiLan with Lantus in 736 patients, that will conclude this quarter. If everything goes according to plan, the French drugmaker plans to file its combination therapy with U.S. regulators in the fourth quarter and European authorities in early 2016.
Meanwhile, Novo Nordisk ($NVO) is pressing forward with a rival combination, pairing its GLP-1 blockbuster Victoza with the insulin Tresiba, which lasts longer than Lantus. The combo, approved in Europe as Xultophy, has posted stellar efficacy results, but the FDA's surprise 2013 rejection of Tresiba has kept it from the U.S. market. In order to get its combo cleared, Novo needs to first convince the agency to change its mind on Tresiba, and the Danish company expects a second decision this winter.
Sanofi's combo efforts haven't been seamless, either. The company was on track to submit lixisenatide for FDA approval in 2013 but, shortly after the Tresiba rejection, pulled its application in order to gather more safety data on the injected therapy. Last month, Sanofi revealed 5-year results showing lixisenatide didn't significantly increase the risk of cardiovascular events, and now the company is planning to resubmit its GLP-1 treatment this quarter.
But the landscape in Type 2 diabetes has changed in the years since lixisenatide's initial delay. Victoza, also a daily treatment, has grown into a $2 billion-a-year standard-bearer, and Eli Lilly's ($LLY) Trulicity, a weekly GLP-1 analog, is threatening its market share. Similarly, Lantus, soon to face biosimilar competition, must now contend with longer-acting products including Tresiba, which is approved in Europe, and Sanofi's own Toujeo.
- read the statement (PDF)