FDA panel recommends approval for two Novo Nordisk insulin products

Approval conditional on post-marketing cardiovascular trial

BAGSVÆRD, Denmark — A Food and Drug Administration panel has voted to support two experimental insulin treatments made by Novo Nordisk, the Danish drug maker said Thursday.

Novo Nordisk said the FDA's Endocrinologic and Metabolic Drugs Advisory Committee had voted 8-to-4 in favor of approval for insulin degludec and a combination treatment containing insulin degludec and insulin aspart.

The FDA is not bound by advisory committee votes when deciding whether or not to approve a drug, but usually follows them. However, the panel also voted unanimously to recommend that after approval, a post-marketing trial be conducted on the drugs to assess their effects on cardiovascular health.

"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," Novo Nordisk EVP and chief science officer Mads Krogsgaard Thomsen said. "We look forward to completing the regulatory process with the agency, including the design of the post-approval cardiovascular outcomes trial."

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