FDA issues response to Novo Nordisk’s request for concizumab approval

Recently Novo Nordisk received a Complete Response Letter from the Food and Drug Administration for concizumab.

Concizumab was submitted for regulatory approval in the U.S. for the treatment of hemophilia A and B with inhibitors in August 2022. In the letter, the FDA requested additional information related to the monitoring and dosing of patients to ensure that concizumab is administered as intended. Furthermore, additional information on the manufacturing process was requested. Novo Nordisk is evaluating the content of the CRL and will work closely with the FDA to provide the requested data. Concizumab has been approved in Canada for the treatment of hemophilia B with inhibitors and is currently under review for the treatment of hemophilia A with inhibitors.