Novo says FDA review of denecimig is still ongoing

• FDA has not set a new timeline for action on the BLA.
• The agency said facility remediation is behind the extended review.
• Novo still aims to launch denecimig in the US in the first half of 2027.

Novo Nordisk said on 2 October 2026 that the US Food and Drug Administration’s review of denecimig for haemophilia A is still ongoing. The agency has not given a new timetable for regulatory action.

Novo says FDA review of denecimig is still ongoing

The FDA told Novo that ongoing remediation at the manufacturing facility is the reason for the extended review. It has not identified any deficiencies in the clinical efficacy or safety data submitted with the BLA.

Novo said it is working with the FDA on the requested remediation steps. The company said the extra review time does not affect its financial outlook for 2026.

Pending a regulatory decision, Novo aims to launch denecimig in the US in the first half of 2027.

Regulatory path

Novo said it submitted the BLA in September 2025 and had expected a decision in the third quarter of 2026. The FDA later carried out a pre-license inspection of the manufacturing site and provided feedback.

The company said the manufacturing-site feedback does not affect other marketed Novo products.

FRONTIER programme

Novo said the FRONTIER clinical programme includes FRONTIER1-5 and is studying denecimig as a prophylactic treatment to prevent bleeding episodes in paediatric and adult patients with haemophilia A, with or without inhibitors.

It said FRONTIER2, FRONTIER3 and FRONTIER4 formed the basis of the denecimig marketing authorisation application submission.

Denecimig

Novo described denecimig as a FVIIIa mimetic bispecific antibody administered under the skin. It said the drug mimics the role of FVIIIa by bridging factor IXa and factor X.

Novo also said denecimig received a positive CHMP opinion on 17 September and is pending marketing approval from the EMA, while other regulators continue their reviews.