Dutch drug maker Novo Nordisk A/S (NVO) announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the United States Food and Drug Administration or FDA has completed its meeting regarding the New Drug Applications or NDA for insulin degludec and insulin degludec/insulin aspart.
At the meeting, the Advisory Committee was asked to discuss the data contained in the NDAs and subsequent submissions regarding the benefits associated with a lower risk of hypoglycaemia and the cardiovascular risk profiles of the two products.
The committee unanimously recommended that a cardiovascular outcomes trial should be conducted and voted eight to four in favour of approving the products with a post approval outcomes trial commitment.
Novo said that the FDA has not informed of the company when it expects to complete its review of the NDAs.
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