Marstacimab (2) – Hympavzi®

• Clinical trials
  • The pharmaceutical manufacturer presents the open-label, single-arm Phase III BASIS trial (B7841005) – an open-label, single-arm Phase III trial forming the basis for marketing authorisation – featuring an intra-individual before-and-after comparison, in which male patients aged between 12 and 74 years with severe haemophilia A (factor VIII activity < 1 per cent) or moderate to severe haemophilia B (factor IX activity ≤ 2 per cent) and a body weight of at least 35 kg.

Adults and adolescents aged 12 years and over with severe haemophilia B <UL><LI>(congenital factor IX deficiency, FIX ˂ 1 %)</LI></UL> without factor IX inhibitors for routine prophylaxis

• The additional benefit is not proven.
• Overall, based on the study presented, for adults and adolescents aged 12 years and over with severe haemophilia B (congenital factor IX deficiency, FIX ˂ 1 %) without factor IX inhibitors, for routine prophylaxis, no additional benefit of marstacimab 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 severe haemophilia B without factor IX inhibitors, the additional benefit of marstacimab compared with the appropriate comparator therapy for routine prophylaxis is not proven.

Courtesy translation only, please refer to the German original.