Novo Nordisk has notified the National Hemophilia Foundation that they have received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for their investigational, subcutaneous therapy concizumab.
Concizumab is manufactured using a synthetically produced (recombinant) antibody derived from a single cell clone, designed to be equally effective in individuals with hemophilia A and B, irrespective of inhibitor status.
The CRL indicates that while the review cycle for the Biologics License Application (BLA) for the therapy has been completed, the application, in present form, is not ready for approval. The agency has subsequently requested additional information in order to re-evaluate the BLA.
While Novo Nordisk had anticipated potential FDA approval of the therapy in the Spring of 2023, the additional information outlined in the CRL will stretch that timeline. The company noted that they will continue to work with the FDA over the coming months to address the questions encompassed in the CRL with an eye towards a resubmission of the BLA.
Source: Novo Nordisk