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Novo Nordisk (NVO) announced Thursday that the U.S. Food and Drug Administration (FDA) declined to approve its once-weekly insulin product, insulin icodec, targeted at patients with diabetes mellitus (DM).
Issuing a complete response letter, the regulator has requested information related to its manufacturing process and the type 1 diabetes indication to complete its review.
“Novo Nordisk is evaluating the content of the CRL and will work closely with the FDA to fulfill the requests,” the Danish drugmaker said, adding that it might not be able to respond to the requests within this year.
The product, identified as insulin icodec, is already available as Awiqli in the EU, Canada, Australia, Japan, and Switzerland for Type 1 and Type 2 DM.
The decision comes after an independent group of experts at the FDA declined to endorse the therapy in an AdCom meeting in May, citing concerns over the drug’s benefit-risk profile in type 1 diabetes.