US FDA delays approval of Novo Nordisk's ultra-long acting insulins
The US Food and Drug Administration has extended the regulatory review period for the ultra-long-acting insulins degludec and insulin degludec/insulin aspart for the treatment of type 1 and type 2 diabetes, under development by Denmark’s Novo Nordisk (NOV: N).
Novo Nordisk revealed this morning that the FDA had informed the company that a three-month extension was required in order to complete its review of the New Drug Applications for the two insulins.
Degludec is potentially the biggest product up for approval this year, according to a recent report by EvaluatePharma, which forecast sales to reach $1.4 billion by 2016 (The Pharma Letter January 20).
Calls for further data clarification
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