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FDA Panel Recommends Approval of Degludec Insulin
The FDA has completed its advisory committee meeting regarding the New Drug Applications (NDAs) for insulin degludec and insulin degludec/insulin aspart (Novo Nordisk).
At the meeting, the committee was asked to discuss the data contained in the NDAs and in subsequent submissions regarding the benefits associated with a lower risk of hypoglycemia and the cardiovascular risk profiles of the two products.
The FDA asked the panel members to vote on whether a cardiovascular outcomes trial should be conducted and on whether sufficient safety and efficacy data had been provided to support marketing of insulin degludec and insulin degludec/insulin aspart.
The committee unanimously recommended that a cardiovascular outcomes trial should be conducted and voted 8 to 4 in favor of approving the products with a post-approval outcomes trial commitment.
The agency has not announced when it expects to complete its review of the NDAs.
Source: Novo Nordisk; November 9, 2012.