The FDA has told Novo Nordisk that its review of the denecimig biologics license application is still running, with no new target date for a decision. That absence of a timeline is the operative fact: Novo filed seeking approval for denecimig in haemophilia A, with or without inhibitors, across adults and children, and the agency has now declined to say when it will act.
Under standard PDUFA review goals, the FDA targets a decision within ten months of filing. A publicly undefined timeline beyond that window signals something more than routine processing, though the agency has not stated why the review remains open. Novo has not indicated whether it received a Complete Response Letter or a request for additional information, which leaves the delay’s cause unresolved from the outside.
The clinical case behind the BLA is reasonably clear. Denecimig’s Phase 3 FRONTIER program showed once-monthly subcutaneous dosing reduced annualized bleed rates in adults and adolescents with or without Factor VIII inhibitors, and extension data presented at ISTH 2026 added longer-term safety. The inhibitor population is the harder segment to treat and the one where existing prophylaxis options have drawn the most commercial and clinical attention, including from Genentech’s emicizumab (Hemlibra), which has been approved in that setting since 2017.
The immediate practical consequence for Novo is that U.S. commercialization planning has no anchor date. Every month the BLA sits unresolved is a month that Hemlibra’s prescribing base deepens, and haematologist familiarity compounds over time. The next concrete thing to watch is whether Novo files a formal dispute-resolution request or discloses a Complete Response Letter, either of which would clarify whether this is a procedural delay or a substantive regulatory obstacle.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
