Concizumab (1) – Alhemo®

Haemophilia A, aged ≥ 12 years, with factor VIII inhibitors

Characteristics

Start date 01.05.2025 – Marketing authorisation: 13.12.2024
Resolution 16.10.2025
INN Concizumab
Brand name Alhemo®
Pharm. company Novo Nordisk GmbH
G-BA Procedure ID D-1187
ATC code B02BX10 Other systemic hemostatics (B02BX)
ICD-10 codes (AIS) D66Hereditary factor VIII deficiency
Alpha-ID codes (AIS) I27819Hemophilia A
Therapeutic area Hematopoietic diseases
Reason for procedure Initial assessment

Therapeutic indication of the resolution

Concizumab is used for the routine prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency) who have FVIII inhibitors, aged 12 years and over.
Subpopulation Indication Comparator
Erwachsene und Jugendliche ab 12 Jahren mit Hämophilie A (kongenitaler Faktor-VIII-Mangel) und Faktor-VIII-Inhibitoren mit Indikation zur Routineprophylaxe

Studies and Results

  • Clinical trials
    • In addition, the pharmaceutical manufacturer presents the multicentre, partially randomised, open-label Explorer7 trial, which formed the basis for marketing authorisation. This trial compared routine prophylaxis with concizumab and on-demand treatment with bypassing agents, and included male patients aged 12 years and over with congenital haemophilia A or B of any severity, as well as factor VIIIor factor IX inhibitors.

Adults and adolescents aged 12 years and over with haemophilia A (congenital factor VIII deficiency) and factor VIII inhibitors, for whom there is an indication for routine prophylaxis

  • For adults and adolescents aged 12 years and over with haemophilia A (congenital factor VIII deficiency) and factor VIII inhibitors, who have an indication for routine prophylaxis, additional benefit is not proven.
  • In its dossier for the assessment of the additional benefit of Concizumab, the pharmaceutical manufacturer does not present any direct comparative studies against the appropriate comparator therapy.
  • Overall, on the basis of the study submitted, no added benefit of Concizumab compared with the appropriate comparator therapy can be concluded for adults and adolescents aged 12 years and over with haemophilia A (congenital factor VIII deficiency) and factor VIII inhibitors, with an indication for routine prophylaxis, no additional benefit for Concizumab can be inferred compared with the appropriate comparator therapy.
  • Overall assessment
    • In the overall assessment, for adults and adolescents aged 12 years and over with haemophilia A (congenital factor VIII deficiency) and factor VIII inhibitors, for whom routine prophylaxis is indicated, the additional benefit of Concizumab compared with the appropriate comparator therapy is not proven.

Courtesy translation only, please refer to the German original.

Associated procedures



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