BRUSSELS (dpa-AFX) - Novo Nordisk A/S (NVO), a pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) informed the company that its Biologics License Application (BLA) review of denecimig for haemophilia A treatment remains ongoing, with no new regulatory timeline communicated.
The FDA cited ongoing facility remediation activities are the cause for the extended review period. However, the agency has not identified any deficiencies related to the clinical efficacy or safety data submitted with the denecimig BLA.
Novo Nordisk submitted the denecimig BLA in September 2025 with an anticipated regulatory decision in the third quarter of 2026. Following the submission, the FDA conducted a pre-license inspection of the manufacturing site and provided feedback.
Novo Nordisk is actively implementing facility remediation activities in response to FDA feedback and working closely with the agency on outstanding requirements. The manufacturing site feedback does not impact other marketed Novo Nordisk products.
The company specified that the extended FDA review time does not affect its financial outlook for 2026. Pending regulatory decision, Novo Nordisk aims to launch denecimig in the U.S. in the first half of 2027.
Denecimig is a FVIIIa mimetic bispecific antibody designed to deliver once-monthly, every-two-weeks, and weekly prophylaxis for people living with haemophilia A, with or without inhibitors.
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