Novo's blockbuster diabetes combo nears EU approval

A committee of European Medicines Agency advisers is recommending approval for Novo Nordisk's ($NVO) combination of a long-acting insulin and its blockbuster GLP-1 drug Victoza, setting the stage for a near-term approval of what's expected to be the diabetes giant's next big therapy.

The drug, to be marketed as Xultophy, is a fixed-dose combo of Victoza, which spurs natural insulin secretion and pushes excess sugar out of the body, and insulin degludec, a once-daily treatment sold outside the U.S. as Tresiba. In its recommendation, the EMA's Committee for Medicinal Products for Human Use (CHMP) praised the cocktail's effect on glycemic control in patients with Type 2 diabetes, pointing to Phase III results in which the treatment improved blood sugar without the weight gain associated with long-acting insulins.

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.

Full EMA approval generally follows within about three months of a CHMP recommendation. However, thanks to an unforeseen regulatory delay, Xultophy's future in the U.S. is much cloudier.

Last year, the FDA rejected Tresiba over cardiovascular risks, telling Novo not to reapply until it had long-term outcomes data demonstrating the insulin's safety. Now the company doesn't expect a U.S. launch for its next-gen insulin until 2017. And, because the agency requires any combo product to be made up of two or more approved treatments, the timeline for a Xultophy filing is up in the air, Novo has said.

Analysts have pegged Xultophy's peak sales at around $1 billion a year, but the cocktail's true potential will remain hard to nail down until Tresiba's status in the U.S. is clear.

The company is staking about $3.7 billion on diabetes R&D to follow up on its blockbuster Victoza, which is facing more and more competition in the GLP-1 space.

- read the CHMP note (PDF)

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

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