Novo Nordisk resubmits the new drug application (NDA) for fast-acting insulin aspart at FDA as a treatment for diabetes.

Novo Nordisk has announced that the company has resubmitted the new drug application (NDA) for fast-acting insulin aspart (known as FIAsp in the EU) as a class II re-submission to the FDA . In October 2016, Novo Nordisk announced that it had received a Complete Response Letter from the FDA regarding the NDA for fast-acting insulin aspart. In the letter, the FDA requested additional information related to the assay for the immunogenicity and the assay used to generate the clinical pharmacokinetics data before the review of the NDA could be completed.

Novo Nordisk has now evaluated the content of the Complete Response Letter and completed the End-of-Review meeting with FDA; based on this, Novo Nordisk has resubmitted the fast-acting insulin aspart NDA as a class II re-submission. Novo Nordisk expects to receive feedback from the FDA in the last quarter of 2017.