Novo touts one-year data for its diabetes tandem therapy

Combine the blockbuster GLP-1 drug Victoza with a long-acting insulin and you get a treatment greater than the sum of its parts, according to Novo Nordisk ($NVO), which unveiled promising new data on its diabetes cocktail IDegLira.

In a 52-week study on 1,663 Type 2 diabetes patients, those taking the combo therapy had a baseline blood glucose of 6.4%, beating out the 7.1% for patients on Victoza and the 6.9% taking Novo's long-acting insulin degludec, marketed as Tresiba. The American Diabetes Association's healthy threshold is 7%, and 78% IDegLira patients hit that mark, compared to 63% on Tresiba and 57% on Victoza. Furthermore, the tandem therapy spurred a roughly one pound average weight loss, as Victoza's positive effect on body weight compensated for the gain common among insulins like Tresiba.

With those stellar efficacy results, Novo believes it has the best in-development one-two punch in the industry, and R&D chief Mads Krogsgaard Thomsen said none of the company's rivals has a GLP-1 receptor agonist up to Victoza's efficacy standard and a long-acting insulin as predictable as Tresiba. That list would include Sanofi's ($SNY) Lyxumia and market-leading Lantus.

"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 CMO for North America, told FierceBiotech.

Novo's rivals will retain a commercial edge, however, thanks to the FDA. IDegLira is currently under regulatory review in Europe, but the combo treatment's U.S. potential is an open question after the U.S. agency rejected Tresiba last year over cardiovascular risks. The FDA told Novo not to come back until it had long-term outcomes data in hand, and 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 an FDA filing is up in the air, Hobbs said. Analysts have pegged IDegLira 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.

But Novo still believes it can get the new insulin onto stateside shelves before its rivals are able to dig in, and its optimism is in part a credit to Sanofi. Earlier this year, in an effort to protect Lantus, Sanofi filed suit to stall Eli Lilly's ($LLY) introduction of a biosimilar, extending the French outfit's market exclusivity and inadvertently stretching Novo's window to introduce its own long-acting insulin before generic competition enters the stage.

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.

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