Novo's Denecimig BLA Review Delayed by FDA Facility Remediation Work

Novo's NVO denecimig biologics license application (BLA) review in the United States is facing an extended timeline after the FDA informed the company that the review of the investigational therapy for haemophilia A remains ongoing. The FDA has not provided a new date for regulatory action, with facility remediation activities cited as the reason for the extension. Novo said the agency has not identified any deficiencies related to the clinical efficacy or safety data included in the application. Novo's denecimig is an investigational FVIIIa-mimetic bispecific antibody being developed as a subcutaneous prophylactic treatment for adults and children with haemophilia A, including patients with inhibitors.