Novo racks up Tresiba data for impending mano a mano with Sanofi's Toujeo

Novo Nordisk is out trumpeting new data on its next-gen basal insulin Tresiba and a combo med, Xultophy. New studies to brag about are always good things. But they're particularly well-timed now, with the FDA on the verge of a decision on Tresiba--and analysts fairly certain that the drug will get the agency's stamp of approval.

After all, Novo ($NVO) will need ammo for its upcoming fight against Sanofi's ($SNY) rival long-lasting basal insulin Toujeo and combo drug LixiLan.

As Reuters reports, analysts see an 80% to 90% chance of approval for Tresiba, which was rejected on its first try in the U.S., thanks to worries about cardiovascular safety. With interim data from a heart trial now in at the FDA, analysts figure that the odds are strong.

"We surmise that the Novo team would not have made the resubmission decision if the FDA raised any major concerns during the discussions," Jefferies analysts said in a note (as quoted by the news service).

It's a key moment for the Danish drugmaker, which specializes in diabetes. It's counting on Tresiba as one big growth driver over the next few years. The ultra-long-acting insulin, already approved alongside some combo meds in Europe, could sell at a premium to shorter-acting products, analysts figure. They see annual sales of $2.4 billion by 2020, Reuters says.

Investors wouldn't be happy if Tresiba got an FDA thumbs-down a second time out. They weren't happy the first time around, either. Novo's growth stats have been impressive for years, and investors want it to keep coming.

That might seem like a given. Diabetes is growing fast worldwide, particularly in developing countries. There's opportunity in the U.S., too; a recent survey found that about half of Americans with diabetes or pre-diabetes have gone undiagnosed.

But diabetes drugs have been under pressure. Discount-hungry payers are pitting drugmakers against one another for price breaks, and Novo has traded some discounts for market share gains. Its basal insulin Levemir, for instance, has gained a few points from Sanofi's rival Lantus. Meanwhile, the company's blockbuster GLP-1 drug Victoza has been coming on strong, but it's now facing new head-to-head competition from Eli Lilly ($LLY). Though category growth is expected to fuel both meds' sales, Victoza has already started to lose market share, despite its sales still rising.

Presented at the European Association for the Study of Diabetes meeting in Stockholm, the Tresiba study showed it matched Sanofi's Lantus at controlling blood sugar in Type 2 diabetes patients, with lower risks of hypoglycemia. And the data on Xultophy, which pairs Tresiba with Victoza, showed that patients on the combo med were more satisfied with their treatment than those taking Lantus. Sanofi, for its part, rolled out LixiLan data at EASD showing that the Lantus-plus-GLP-1 combo delivered better results than Lantus.

- read the Novo release (PDF)
- get more from Reuters

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Editor's note: This story was updated to indicate that Tresiba showed non-inferiority in a trial against Lantus. 

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