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FDA Panel Recommends Approval of Degludec Insulin
Cardiovascular outcomes trial will be required (Nov. 9)
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.