Novo Nordisk today announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the United States Food and Drug Administration (FDA) has completed its meeting regarding the New Drug Applications (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 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 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 eight to four in favour of approving the products with a postapproval outcomes trial commitment.
“The positive vote from the Advisory Committee marks an important step towards making insulin degludec and insulin degludec/insulin aspart available to patients with diabetes in the US. We look forward to completing the regulatory process with the agency, including the design of the post-approval cardiovascular outcomes trial,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.
The FDA has not informed Novo Nordisk of when it expects to complete its review of the NDAs.
Image courtesy of Armin Kübelbeck.
