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FDA delays denecimig BLA review due to facility remediation; aims for US launch in H1 2027
NVONovo Nordisk A S
The US Food and Drug Administration (FDA) has informed Novo Nordisk that the Biologics License Application (BLA) review for denecimig, a treatment for haemophilia A, remains ongoing due to facility remediation activities. The FDA did not identify deficiencies in the clinical efficacy or safety data from the FRONTIER trial programme. Novo Nordisk is actively addressing manufacturing site feedback and expects no impact on its 2026 financial outlook. Pending regulatory approval, the company aims to launch denecimig in the US in the first half of 2027. Novo Nordisk A/S is a global healthcare company that develops treatments for diabetes, obesity, rare diseases, and other serious conditions.