The FDA Delays Novo Nordisk's degludec and degludecPlus Insulins and Schedules an Advisory Committee Meeting to Discuss the Drugs
By Adam Brown
As noted in new now next in diaTribe #37, Novo Nordisk announced in October 2011 that it had submitted its two new “next-generation” insulin products for approval in the US. The first product, called degludec, is an ultra-long acting basal insulin. The second product, called degludecPlus, is a fixed-dose combination of basal and mealtime insulin (70% degludec and 30% NovoLog). In late July, the FDA decided to delay an approval decision on degludec and degludecPlus until after a November 8 advisory committee, where a panel of experts will meet and recommend whether FDA should approve the new insulins (FDA does not have to follow the committee’s recommendation, though it typically does). We have heard that the FDA is going to require advisory committees for every new diabetes drug unless there are specific reasons not to, although this news came as a bit of a surprise because it was announced so late in the review process. A possible reason for the delay could be that the FDA is being more cautious due to degludec’s relatively new features, including its potential for more flexible dosing and its extended, 25-hour half-life in the body. We are not aware of any significant safety risks that would hold up the approval process. While the original hope was for both drugs to be approved in the second half of 2012, this likely pushes back the approval timeline to very late this year or, more likely, sometime in 2013. Assuming there are no further delays in the degludec approval process, we do not think this news will materially affect the timeline for IDegLira (a combination of degludec and Victoza) – as a reminder, that is on track for FDA approval by the end of 2013 at the earliest. –AW/AB
