An FDA advisory committee handed Novo Nordisk ($NVO) a rousing endorsement for its diabetes combo IDegLira, voting 16 to 0 on Tuesday to back the company’s marketing application.
The vote came after FDA insiders raised a number of objections to the application, including a potential bias in the study design in favor of the combo. But none of those objections are expected to get in the way of a final OK at this point. Panelists seemed largely content that practitioners could identify the patients most likely to benefit from a single injection fixed combination of insulin degludec (Tresiba) and liraglutide (Victoza).
“Where I was impressed with this product,” noted panel member Charles Stanley, professor of pediatrics at the University of Pennsylvania Perelman School of Medicine, “we’re actually talking about normalizing fasting glucose and hemoglobin A1c. I think that it may be a new era for type 2 diabetes.”
Right behind Novo, Sanofi ($SNY) is lining up for an FDA panel Wednesday on iGlarLixi, a combination of Lantus with the GLP-1 drug Lyxumia (lixisenatide), now under review. Tuesday’s positive outcome for Novo may well set up a head-to-head marketing battle between the two diabetes players.
IDegLira is widely considered a key product for Novo, which is an aggressive player in the high-stakes battle over a growing multibillion-dollar global market. The combo was held up by a serious delay on Tresiba, which was approved in the U.S. last fall after a two-year delay.
Analysts have pegged peak sales of IDegLira, already approved in Europe as Xultophy, at around $1 billion. The big idea here is that a combo would provide diabetics a better way to control blood sugar while eliminating some of the complications associated with insulin use.
The vote by the committee leaves the door wide open to an official approval by the FDA.
"The unanimous recommendation from the Advisory Committee marks an important step towards making IDegLira available to adults with type 2 diabetes in the US. We look forward to working with the FDA as they complete their review of IDegLira," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.
- here's the release
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