Degludec not approved in US
Novo Nordisk must finish a cardiovascular outcomes trial and correct deficiencies at its principal manufacturing plant before the FDA will approve its long-acting insulin degludec drugs.
The FDA in US sent the company a ”complete response letter” indicating that it was not ready to approve insulin degludec (Tresiba) or a combination product with insulin degludec and insulin aspart (Ryzodeg) for diabetic patients requiring insulin. They are intended for once-daily, anytime dosing, which is not possible with existing insulin drugs.
An FDA advisory committee voted 8-4 last November to recommend approval, but panel members had expressed concern about a possible increase in cardiovascular events with insulin degludec. Pooled data from 16 trials with the agent identified a 10% higher rate of serious events in patients receiving it versus other insulin forms.
Panel members were unanimous in recommending that FDA order a special cardiovascular outcomes study, but most indicated that it could be conducted after approval.
The complete response letter also indicated that Novo would have to resolve violations cited in a Dec. 12, 2012 warning letter about problems at the company’s production facility in Bagsvaerd, Denmark. FDA inspectors cited multiple deficiencies in quality control testing and also noted that workers in the plant’s ”aseptic core” were wearing unsterilized goggles.
In its announcement Sunday of the complete response letter, Novo said it was ”surprised and disappointed” by the rejection, but said it would work with the FDA ”to determine the best path forward to completing the review.”
Final approval will likely be delayed at least until 2014. Novo said it would be unable to submit the required cardiovascular outcomes data this year.
Novo Nordisk Press Release
From www.diabetesuncontrol.com
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