美国食品药品监督管理局批准了瑞公司的Hympavzi用于血友病A/B预防,这是第一个非因子每周治疗. FDA approves Pfizer's Hympavzi for hemophilia A/B prophylaxis, first non-factor weekly treatment.
美国食品和药物管理局批准了瑞公司的Hympavzi (marstacimab-hncq) 作为常规预防药物,用于预防12岁及以上的血友病A或B缺乏特定抑制剂的患者出血. The FDA has approved Pfizer's Hympavzi (marstacimab-hncq) for routine prophylaxis to prevent bleeding in patients aged 12 and older with hemophilia A or B lacking specific inhibitors. 这标志着 B 型血友病的首次非因素、每周一次的治疗。 This marks the first non-factor, once-weekly treatment for hemophilia B. 通过自动注射器施用,Hympavzi通过降低组织因子通路抑制剂水平而起作用,从而增加血栓因子,改善凝血. Administered via an auto-injector, Hympavzi works by reducing tissue factor pathway inhibitor levels, leading to increased thrombin for improved clotting. 核准的依据是一项有116人参加的研究。 The approval is based on a study with 116 participants.