Novo Nordisk Gets FDA Complete Response Letter For Faster-acting Insulin Aspart

(RTTNews) - Novo Nordisk (NVO) announced the receipt of a Complete Response Letter from the US Food and Drug Administration regarding the New Drug Application for faster-acting insulin aspart. The NDA for faster-acting insulin aspart was submitted to the FDA in December 2015.

In the letter, the FDA requests additional information related to the assay for the immunogenicity and clinical pharmacology data before the review of the NDA can be completed.

Novo Nordisk said it is evaluating the content of the letter and will work closely with the regulatory to resolve the outstanding issues. Faster-acting insulin aspart is currently also under review in the EU, Switzerland, Canada, Brazil, South Africa and Argentina.

Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk, said "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"