The FDA has extended its review of Novo Nordisk’s experimental hemophilia A treatment denecimig after a pre-approval inspection identified manufacturing-site issues requiring ongoing remediation.
Novo had expected a decision in the third quarter of 2026; the FDA has not provided a new decision date.
Novo says the FDA has not identified deficiencies in denecimig’s clinical safety or efficacy data. The company also says the manufacturing feedback does not affect its other marketed medicines.
Novo is working with the FDA on the facility corrections. The company says the delay does not change its 2026 financial outlook and is still targeting a U.S. launch in the first half of 2027, pending approval.
Sources:
Novo provides update on the denecimig Biologics License Application (BLA) in the US
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