Novo Nordisk wins EU approval for a diabetes combo with billion-dollar potential

Novo Nordisk ($NVO) picked up European approval for a combination of a long-acting insulin and its own Victoza, pioneering a once-a-day approach to Type 2 diabetes that could bring in blockbuster sales.

The drug pairs Tresiba, an insulin analog that lasts for up to 40 hours, with Victoza, which bolsters the hormone GLP-1 to promote the body's natural production of insulin. Branded as Xultophy, Novo's new combo will ship in a single injector pen, and the company expects to roll it out across Europe in the first half of next year.

In 52-week data presented at June's American Diabetes Association conference, patients taking the combo therapy had baseline blood glucose of 6.4%, beating out the 7.1% for patients on Victoza and the 6.9% taking Tresiba. The ADA's healthy threshold is 7%, and 78% of Xultophy patients hit that mark, compared to 63% on Tresiba and 57% on Victoza.

Beyond being first in line, Novo believes it has the best one-two punch across all of diabetes R&D, and company executives have said none of their rivals has a GLP-1 receptor agonist up to Victoza's efficacy standard and a long-acting insulin as predictable as Tresiba.

"Personally, professionally and as a clinician, I've never seen data as robust as what we're seeing with the dual program," Todd Hobbs, Novo's Chief Medical Officer for North America, told FierceBiotech at the ADA conference.

Analysts have estimated peak sales for Xultophy at more than $1 billion worldwide, bolstering the roughly $2 billion a year Victoza pulls in on its own.

However, thanks to Tresiba's surprise FDA rejection last year, the combo's stateside fate remains on hold.

Citing unexplored cardiovascular risks, the agency turned away Novo's long-acting insulin in 2013, telling the company to come back when it had long-term outcomes data to support the injection's safety. And, because the FDA requires any combo product to be made up of two or more approved treatments, Xultophy will have to wait.

But Novo is moving nearly a year ahead of schedule, last month revealing that it should have new Tresiba data ready by year's end, lining it up to potentially win approval in early 2016.

- read the announcement (PDF)

Special Report What's next in diabetes drugs? The pulse of R&D at ADA14

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