The US Food and Drug Administration has informed Novo Nordisk that its Biologics License Application review of denecimig for the treatment of haemophilia A, with or without inhibitors in adults and children, is still ongoing, with no new timeline communicated for regulatory action. The FDA attributed the extension to ongoing facility remediation activities at the manufacturing site, and Novo said the agency has not identified any deficiencies related to the clinical efficacy or safety data submitted in the BLA. Novo submitted the application in September 2025 with an anticipated decision in the third quarter of 2026, and is now working with the FDA to address its remediation requests. The additional review time does not affect Novo's financial outlook for 2026, and pending a regulatory decision the company aims to launch denecimig in the US in the first half of 2027. Denecimig, a FVIIIa mimetic bispecific antibody administered under the skin, received a positive CHMP opinion on 17 September and is pending marketing approval from the EMA and under review by other regulatory authorities.
Novo Nordisk A/SFDA extended its review of Novo's denecimig BLA for haemophilia A due to facility remediation, delaying a potential US launch to H1 2027.
