Biotechnology
Novo Says FDA Extends Denecimig BLA Review Over Facility Remediation
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Novo Nordisk said in a company announcement on 2 October 2026 that the US Food and Drug Administration has extended its review of the Biologics License Application (BLA) for denecimig for the treatment of haemophilia A, with the agency citing ongoing remediation activities at the manufacturing facility as the cause. The FDA has not communicated a new timeline for regulatory action on the application, and Novo said the additional review time has no impact on its financial outlook for 2026.
The application covers the treatment of haemophilia A, with or without inhibitors, in adults and children. Novo submitted the BLA to the FDA in September 2025 and had anticipated a regulatory decision in the third quarter of 2026. Following the submission, the FDA performed a pre-license inspection of the manufacturing site and provided feedback.
According to the announcement, the FDA informed Novo on 2 October 2026 that the ongoing facility remediation activities are the cause for the extension of the review, and that the agency has not identified any deficiencies related to the clinical efficacy or safety data submitted in the BLA from the FRONTIER clinical trial programme. Novo said it is continuing implementation of the facility remediation activities in response to the FDA’s feedback and is working with the agency to address the outstanding requirements. The feedback on the manufacturing site does not impact other marketed Novo products.
“Novo is already in the process of addressing the FDA’s requests as efficiently as possible and continuing to work closely with the Agency toward bringing denecimig to patients in the US,” said Mike Doustdar, president and CEO of Novo.
Pending the regulatory decision, Novo said it aims to launch denecimig in the US in the first half of 2027.
FRONTIER Clinical Programme
The BLA included efficacy and safety data from the FRONTIER clinical trial programme, which includes the FRONTIER1 through FRONTIER5 trials and investigates denecimig as a prophylactic treatment to prevent bleeding episodes across paediatric and adult populations with haemophilia A, with or without inhibitors. FRONTIER2, FRONTIER3 and FRONTIER4 formed the basis of the denecimig Marketing Authorisation Application submission. FRONTIER2 evaluated denecimig once every month and once every week in adults and adolescents 12 years of age and older, while FRONTIER3 evaluated monthly and weekly dosing in children below the age of 12. FRONTIER4 was an open-label extension trial evaluating the efficacy of denecimig once every two weeks as well as the long-term safety of denecimig across all dosing regimens.
Novo has reported that in the pivotal FRONTIER2 trial, denecimig significantly reduced the annualised bleeding rate compared to prior clotting factor prophylaxis and on-demand treatment in people with haemophilia A, with or without inhibitors. According to the company, results from FRONTIER3 in children younger than 12 years were consistent with the efficacy observed in adolescents and adults, and across the FRONTIER programme denecimig demonstrated consistently low mean annualised bleeding rates, generally below 1 in the reported phase 3 population, with a substantial proportion of participants experiencing zero treated bleeds. In the FRONTIER5 trial, no new safety signals were identified following direct switching from emicizumab to denecimig prophylaxis, and the study showed a clear preference for the denecimig device, according to Novo. Data from FRONTIER2 were published in the New England Journal of Medicine, and data from FRONTIER5 were published in the Journal of Thrombosis and Haemostasis.
European Regulatory Status
On 17 September 2026, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending marketing authorisation for denecimig, under the brand name FREHEMGO, to treat haemophilia A, with or without inhibitors, in adults and children, according to a separate company announcement. The product remains pending marketing approval from the European Medicines Agency and is under review by other regulatory authorities. Novo has described FREHEMGO as the first FVIIIa mimetic to offer once-monthly, once-every-two-weeks and once-weekly prophylaxis in a single-use pre-filled pen, and said it expects to launch the product in the first European countries in the fourth quarter of 2026 and broadly across the EU starting early 2027.
Denecimig is a FVIIIa mimetic bispecific antibody administered under the skin. It is designed to deliver once-monthly, once-every-two-weeks and weekly prophylaxis for people living with haemophilia A, with or without inhibitors. The antibody bridges factor IXa and factor X, mimicking the cofactor function of FVIIIa, an action that helps restore the body’s thrombin generation capacity and helps blood to clot.
The 2 October 2026 update was published from Bagsværd, Denmark, as company announcement No 59/2026 and as a publication of inside information pursuant to Article 17 of the Market Abuse Regulation.
