The FDA has extended its review of Novo Nordisk’s denecimig application because of ongoing manufacturing facility remediation, the company said. The agency has not provided a new timeline for a regulatory decision.
Denecimig is under review for treating hemophilia A in adults and children, with or without inhibitors. Novo submitted its biologics license application in September 2025 and had anticipated a decision in the third quarter of 2026.
Following submission, the FDA conducted a pre-license inspection of the manufacturing site and provided feedback. Novo said it is implementing remediation activities and working with the agency to address outstanding manufacturing requirements.
The FDA has not identified deficiencies in the clinical efficacy or safety data submitted from the FRONTIER trial program, according to Novo. The company said the manufacturing-site feedback does not affect its other marketed products.
Novo said the extended review does not change its financial outlook for 2026. Subject to a regulatory decision, it aims to launch denecimig in the United States during the first half of 2027.
Denecimig is a bispecific antibody administered under the skin. It mimics the function of activated factor VIII by bridging factor IXa and factor X, helping restore thrombin generation and blood clotting.
The FRONTIER program evaluates the drug as preventive treatment against bleeding episodes. Studies have assessed weekly, every-two-week and monthly dosing across adult and pediatric populations.
Denecimig received a positive opinion from the European Medicines Agency’s human medicines committee on Sept. 17. European marketing approval remains pending, alongside reviews by other regulatory authorities.
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