Novo Nordisk’s combination diabetes drug didn’t lap Sanofi’s after all. Two weeks after the FDA put off approval of the French drugmaker’s insulin-plus-GLP-1 combo, the agency has pushed back Novo’s, too.

The FDA says it’s extending its review by three months, with a decision date now in December. The delay once again puts Xultophy slightly behind Sanofi’s LixiLan. Novo didn’t offer any details about the FDA’s reasoning.

The combination meds both have blockbuster prospects, with a $6 billion market potential between them. Both companies are counting on these drugs to rev up sales as their diabetes products suffer increased pricing pressure and competition from a wave of newer therapies.

Xultophy combines Novo’s big-selling GLP-1 drug Victoza and its newest basal insulin, Tresiba. The Danish drugmaker’s R&D chief, Mads Krogsgaard Thomsen, has said that the combination product has some of the strongest late-stage data he’s ever seen. “If not the strongest,” Thomsen told the Danish pub Jydske Vestkysten last fall.

“I think you can expect as much of Xultophy as of Tresiba,” Thomsen said at the time.

Bernstein analyst Ronny Gal agrees; he figures that Xultophy isn’t simply a convenience-oriented duo product as combo meds often are. Xultophy “nicely balanced the side effects of two drugs,” Gal says, which allowed researchers to step up dosages safely in treat-to-target trials.

Plus, the drug’s payoff in clinical studies was impressive–“a bit of ‘shock and awe’ in the absolute impact of Xultophy on patients who started on the drug after oral therapy,” Gal said earlier this year in an investor note, citing close to 2% benefit in HbA1c, a barometer of blood sugar management.

The Danish drugmaker has been pushing hard to establish Tresiba, the basal insulin half of the Xultophy combo. An expanded U.S. salesforce is promoting the drug’s dosing advantage–it can be taken any time of day, rather than on a strict schedule as older basal insulins must–while  a direct-to-consumer advertising campaign launched on TV this spring. By July, the drug had hit FiercePharma’s top 10 TV ad spenders, with $8.4 million laid out on two spots.

Thomsen said Novo wants doctors to see Tresiba as “the preferred basal insulin, as Victoza is the preferred GLP-1,” Thomsen said, because if that’s the case, doctors will see the combination med and think, ‘[I]t must be good.’ “

Sanofi has its own ambitions for LixiLan, however. Also known as IGlarLixi, that combo pairs the French drugmaker’s new-to-the-U.S. GLP-1 Adlyxin (lixisenatide) with its long-dominant basal insulin Lantus (insulin glargine). The latter will face biosimilar competition in the U.S as of December, making Sanofi’s newer products even more important to its diabetes franchise.

And there’s another wrinkle for Xultophy: Victoza is quickly losing market share to Eli Lilly’s long-acting GLP-1 med Trulicity. Victoza is still growing sales, but at a slower rate. Novo won’t have its own long-acting GLP-1, semaglutide, on the market till mid-2017 at the earliest. The company expects to submit it for FDA approval by the end of this year.

But don’t count out Victoza or Xultophy yet. Novo may soon be able to  brag about new cardiovascular outcomes data showing Victoza reduces the risk of cardiovascular death by 22% and overall CV risks by 13%. That study, LEADER, was presented at the American Diabetes Association’s Scientific Sessions in June, and the company expects to submit the data to the FDA for a label addition.

Sanofi’s Adlyxin/Lyxumia, by contrast, didn’t achieve the same feat. Its cardiovascular outcomes trial showed that the drug didn’t increase cardiovascular risks, but did not reduce them, either. That could give Xultophy a further selling point. “We know it is not a class-wide effect,” Dr. Todd Hobbs, Novo’s chief medical officer, told FiercePharma at the ADA meeting. “So far, it is specific to liraglutide,” though top-line data on Novo’s weekly GLP-1 drug semaglutide recently showed a statistically significant decrease in CV risks as well.

As for the Tresiba side of Xultophy, Novo also has more data showing it can reduce the risk of hypoglycemia, a much-feared side effect of insulin treatment, compared with Sanofi’s Lantus. It’s hoping to persuade the FDA to add that benefit to Tresiba’s official label, which would allow Novo to tout that benefit, too.

Novo will be marshaling this data and more to persuade payers that Xultophy is worth the cost, at a time when diabetes drugmakers face unprecedented pressure on their pricing. Pharmacy benefits managers are trading big discounts for preferred status on their formularies, pushing net prices down across the category. Express Scripts, for one, excluded Novo’s Victoza and Tresiba from its 2017 formulary, giving preferred status to rivals from Eli Lilly.

Source: http://www.fiercepharma.com/

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