With LixiLan decision date set, Sanofi nears another head-to-head contest with Novo

Sanofi ($SNY) has pulled out all the stops to get its LixiLan combo med approved quickly, and now it's in the hands of the FDA. Decision deadline: August. Sales prospects? That's the big question.

The diabetes combo pairs Sanofi's now-blockbuster basal insulin Lantus with its new GLP-1 drug Lyxumia, and like the French drugmaker's other diabetes meds, faces a head-to-head rival from Novo Nordisk ($NVO). That's Xultophy, which combines Novo's blockbuster GLP-1 Victoza with its new longer-acting insulin Tresiba.

Xultophy is approved in Europe but not in the U.S., where a delay on Tresiba held up plans for filing the combo. Lyxumia faced its own delay at the FDA, too, with a decision now due in July. Now, Sanofi's idea is to beat the Novo combo product to market and gain traction ahead of a Xultophy launch. It sees the head start as so important that it used a priority review voucher--purchased for $150 million--to cut review time at the agency.

Both companies have racked up study data that they plan to use in their market-share contest, with each boasting some sort of edge. Sanofi has cardiovascular outcomes data on Lyxumia showing that the drug didn't increase cardiovascular risks--though it didn't decrease them either. LixiLan bested Lantus alone in a head-to-head trial, showing its utility for the 50% of basal insulin patients whose blood sugar isn't controlled, the company says.

Sanofi EVP and diabetes/CV chief Pascale Witz

"The FDA filing notification is an important milestone for Sanofi as we work to broaden our diabetes portfolio," EVP and diabetes/CV chief Pascale Witz said in a Monday statement. "Physicians may need to consider fasting and mealtime blood glucose imbalances in their overall management of diabetes, and additional treatment options are needed.

Meanwhile, Victoza is still waiting on its cardiovascular trial, so it has no data to tout there. But then again, those outcomes data are due later this year, and Novo executives see some chance that it will indeed show a positive CV benefit.

The fact that Tresiba--rather than an older Novo basal insulin--is part of the Xultophy combo could also be a selling point for the Danish drugmaker. Tresiba is a longer-acting product that Novo is working hard to promote, partly with the eventual launch of Xultophy in mind.

"I think you can expect as much of Xultophy as of Tresiba," Novo R&D chief Mads Krogsgaard Thomsen predicted last year in an interview with JydskeVestkysten, saying that the combo product has some of the strongest late-stage data he's ever seen. "If not the strongest," he said.

Meanwhile, as it revs up for a LixiLan launch, Sanofi is continuing to push its next-gen basal insulin Toujeo in hopes of moving as many Lantus patients over as possible before a biosimilar version of the drug makes its U.S. debut in December. The drug ginned up €98 million in the fourth quarter, beating projections of just €69 million.

- see the release from Sanofi

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