FDA delays US approval of Novo Nordisk's faster-acting insulin aspart, issuing a CRL

Danish diabetes care giant Novo Nordisk (NOV: N) revealed on Friday that it has received a Complete Response Letter from the US Food and Drug Administration regarding the New Drug Application for faster-acting insulin aspart.

In the letter, the FDA requests additional information related to the assay for the immunogenicity and clinical pharmacology data before the review of the New Drug Application can be completed. Novo Nordisk is evaluating the content of the CRL and will work closely with the FDA to resolve the outstanding issues.

"We believe faster-acting insulin aspart can address an unmet medical need for people requiring improved blood glucose control around meals, and our ambitions for this innovative drug are unchanged," says Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk, adding: "We acknowledge the request for information from FDA and will work closely with the agency to determine the best path forward to complete the review."