Novo provides update on the denecimig Biologics License Application (BLA) in the US

Novo Nordisk A/S The US Food and Drug Administration (FDA) has informed Novo that the BLA review of denecimig for the treatment of haemophilia A is still ongoing. The FDA has not communicated a new timeline for regulatory action on the BLA The FDA has informed Novo that the ongoing facility remediation activities are the cause for extension of the Agency's review. The FDA has not identified any deficiencies related to the clinical efficacy or safety data submitted in the denecimig BLA Novo is actively working with the FDA, addressing the Agency's requests for remediations related to the manufacturing facility.