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Efficacy and Safety of Concizumab Prophylaxis in Patients With Haemophilia A or B Without Inhibitors

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Trial Profile

Efficacy and Safety of Concizumab Prophylaxis in Patients With Haemophilia A or B Without Inhibitors

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 21 Aug 2025

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At a glance

  • Drugs Concizumab (Primary)
  • Indications Haemophilia A; Haemophilia B
  • Focus Registrational; Therapeutic Use
  • Acronyms explorer8
  • Sponsors Novo Nordisk

Most Recent Events

  • 31 Jul 2025 According to a Novo Nordisk media release, company announced that the US Food and Drug Administration (FDA) approved Alhemo (concizumab-mtci) injection as a once-daily prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A or B (HA/HB) without inhibitors, expanding on the December 2024 approval for HA/HB with inhibitors.
  • 25 Jul 2025 According to a Novo Nordisk media release, The trial is ongoing in the extension phase and is expected to complete in 2028
  • 25 Jul 2025 According to a Novo Nordisk media release, company announced that the European Medicines Agencys Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending an update of the Alhemo (concizumab) label to include the treatment of severe haemophilia A and moderate or severe haemophilia B without inhibitors.

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