Sanofi's combo med LixiLan ready to go to FDA in ongoing scramble for diabetes dominance

Sanofi's diabetes franchise faces attack on multiple fronts, with its top-selling Lantus soon to go up against biosimilar competition and several meds facing stepped-up pricing pressures--not to mention new rivals from Eli Lilly & Co. ($LLY) and Novo Nordisk ($NVO) either already launched or on their way. But the French drugmaker has racked up another set of positive data on a new combo med that could help fortify its sales.

Study investigator Richard Bergenstal

A second late-stage study of LixiLan, which marries its GLP-1 drug Lyxumia and the basal insulin Lantus, came up positive, Sanofi ($SNY) announced Monday. The study tested LixiLan in patients who were struggling to control their blood sugar despite basal insulin treatment alone and found that those taking LixiLan saw better results than those taking Lantus, with or without metformin.

"The result highlights that this could provide a treatment option for the roughly 50% of patients who are no longer able to remain at their HbA1c target, despite basal insulin treatment," study investigator Richard Bergenstal of the International Diabetes Center in Minnesota said in a statement.

The LixiLan-L trial news follows last month's presentation of ELIXA data, which showed that Lyxumia didn't increase cardiovascular risks--though it didn't decrease them, either. Sanofi pulled Lyxumia's approval app from the FDA in late 2013 to wait for the safety data, and now plans to resubmit the drug by the end of this month.

Right on its heels will be a submission for LixiLan, which Sanofi plans to file next quarter at the FDA, hoping for a decision in 2016. A European filing is planned for the first quarter of next year.

LixiLan would be the latest in a series of new additions to Sanofi's diabetes portfolio, including the inhaled insulin Afrezza, launched in the U.S. in February, and Toujeo, the long-acting Lantus follow-up rolled out in the U.S. in April. Lyxumia has already launched in Europe, and could make its U.S. debut ahead of LixiLan.

LixiLan's particular selling point is that it's the only fixed-dose combo pairing basal insulin and a GLP-1. "This is a very synergistic combination," Sanofi EVP Peter Guenter said during the company's first-quarter earnings call, adding that the drug had been "a little bit overlooked" by financial analysts at that point. "I must say we are pretty excited about this product."

- read the Sanofi release

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