NOVO NORDISK is seeking the FDA approval of concizumab, an investigational therapy for patients with hemophilia A and B with inhibitors. While NOVO NORDISK was expecting an FDA approval in Q2 2023, the company received a Complete Response Letter (CRL).
A CRL is issued when the Agency has completed its review of an application for a new drug or biologic and it is not yet ready to approve it in its present form, which means additional information is required to re-evaluate the submission. Receiving a CRL during the first submission cycle is not uncommon: 24% of new drugs approved in 2022 were the result of more than one cycle of the Biologics License Application (BLA) and New Drug Applications (NDA). 1
The FDA issued a CRL because the Agency is requesting additional information to assist physicians and to help ensure patients have the appropriate levels of concizumab. Novo Nordisk is currently working closely with the FDA to address their questions and will continue to work with the Agency during the coming months as it plans for resubmission. NOVO NORDISK is confident in the potential of concizumab to address a significant unmet need in hemophilia patients with inhibitors, particularly for people with hemophilia B with inhibitors, and is committed to bringing this important treatment to market.
For more than 30 years, Novo Nordisk has gained the experience and trust of HCPs, patients, and the hemophilia community. While this news is disappointing, NOVO NORDISK continues to be committed to hemophilia patients and providers to ensure that existing and new therapies are developed to meet the unmet needs of patients. NOVO NORDISK will continue to work urgently to provide new treatments to the hemophilia community.