FDA review of Novo Nordisk’s denecimig for haemophilia A runs longer as manufacturing facility remediation continues

The US Food and Drug Administration has told Novo Nordisk that its review of the Biologics License Application for denecimig, a treatment for haemophilia A with or without inhibitors in adults and children, is still under way. The agency has not given a new date for a decision.

Novo Nordisk filed the application in September 2025 and had expected a regulatory decision in the third quarter of 2026. After the submission, the FDA carried out a pre-license inspection of the manufacturing site and passed on its feedback. The agency has now said that remediation work still going on at the facility is the reason its review has been extended.

Importantly for the drug itself, the FDA has not found any problems with the clinical efficacy or safety data produced in the FRONTIER clinical trial programme. Novo Nordisk is pressing ahead with remediation work in response to the agency’s feedback and is working closely with the FDA to meet the outstanding requirements. The company said the feedback about the manufacturing site does not affect its other marketed products.

Mike Doustdar, president and chief executive officer of Novo Nordisk, said people with haemophilia A should expect more from their standard of care, and that as the company prepares to bring denecimig to market it wants to make better care something they can rely on. He said Novo Nordisk is already dealing with the FDA’s requests as quickly as it can and continuing to work closely with the agency to get denecimig to patients in the US.

The longer review does not change Novo Nordisk’s financial outlook for 2026. Depending on the regulatory decision, the company aims to launch denecimig in the US in the first half of 2027.

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FDA, haemophilia A, Novo Nordisk