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Novo Nordisk and Sanofi both got good news this week when an FDA advisory panel backed their new combination drugs. And if the FDA follows that committee’s advice, the two products will go head to head in a brand-new market with $6 billion-plus potential.

Both companies will be looking for an edge, and the details of the FDA’s labeling decisions will be key. If either company scores a labeling advantage, that could make a big difference in sales down the line.

But both drugs will face marketing challenges. Payers have been more reluctant to give combination products favorable spots on recent formularies, for one thing. And analysts predict that both launches are likely to be slow.

The two drugs–Novo’s Xultophy and the as-yet-unnamed Sanofi product, dubbed internally as LixiLan–pair basal insulins with GLP-1 drugs. In Novo’s case, that’s Tresiba, its new, longer-lasting insulin, and Victoza, its top-selling GLP-1 drug. In Sanofi’s, it’s the long-dominant Lantus, which gets biosimilar competition in the U.S. later this year, and the newer GLP-1 med sold as Lyxumia overseas. The FDA advisory committee that handles diabetes treatments backed Novo’s product unanimously, and Sanofi’s in a 12 to 2 vote.

Novo’s Xultophy has been tipped as more likely to win the better label, partly because Novo tested the drug specifically in patients whose blood sugar wasn’t well controlled on GLP-1 drugs. Sanofi’s product hasn’t yet undergone the same test, though the French drugmaker does plan a similar study.

“[W]e believe there is a potential for LixiLan to receive a slightly narrower label in terms of patient population than Xultophy, at least initially,” Leerink Partners analyst Seamus Fernandez wrote in a Wednesday note after the LixiLan panel vote.

For that reason–and for differences in the delivery devices; the FDA panel saw safety questions with both, but apparently had more concern about Sanofi’s–Leerink forecasts about $5 billion in peak sales for Xultophy and $1.5 billion to $2 billion for LixiLan.

Bernstein analyst Ronny Gal pointed up some differences in trial data for Xultophy and LixiLan, with the Novo product delivering slightly better blood sugar results compared to Lantus than LixiLan’s. Weight loss results appeared to be slightly better for Xultophy as well, Gal said, though he noted that full data from all of the combo product studies isn’t yet available, so comparisons are limited.

Gal sees Xultophy as a potential “best” product for diabetes, according to a recent investor note. But he also sees pricing as an obstacle, because Victoza is pricier than insulin alone. Bernstein expects Novo to price the combo product at $25 to $30 per day, at least $9 more than an insulin regiment, he said. “Payers will find Xultophy expensive,” Gal stated bluntly.

And this is where LixiLan might find an advantage. Sanofi could “primarily view the drug as a protection mechanism for Lantus and will price it at modest price increase to the single agent Lantus, creating pricing pressure on the category,” Gal noted.

Both companies are relying on the new combos to pitch in sales growth, as competition from new drugs–and the Lantus biosimilar, on tap for December–heat up the battle for diabetes market share. Eli Lilly and Boehringer Ingelheim have a new GLP-1 med, Trulicity, that’s gaining share from Victoza, and the same two partners market the SGLT2 med Jardiance, which last year became the first diabetes drug to show cardiovascular benefits in a clinical trial. Since then, Victoza has racked up its own CV data, but Jardiance has already won an FDA label change.

By Tracy Staton

Source: Fierce Pharma