I te 11 o Oketopa 2024, ka whiwhi a Hympavzi (marstacimab-hncq), he antibody monoclonal tangata e aro ana ki te "kaiwhakahoki arai arai kiko" i te US. FDAKo te whakaaetanga hei rongoa hou mo te aukati i nga wahanga whakaheke toto i roto i nga tangata whai hemophilia A, hemophilia B ranei.
I mua ake nei, i te 19 o Hepetema 2024, i whakawhiwhia ki a Hympavzi te mana hokohoko e te European Medicine Agency (EMA) mo te aukati i nga waahanga whakaheke toto i nga turoro he mate hemophilia A, B ranei.
Ko te Hemophilia A he mate whakaheke toto na te korenga o te tauwehe toto toto VIII i te mea ko te hemophilia B na te ngoikore o te tauwehe IX. Ko nga tikanga e rua he rongoa tikanga ma te whakakapi i nga mea whakaheke toto e ngaro ana ma te werohanga.
Ka aukati a Hympavzi i nga wahanga toto ma te rereke rereke. Ka aro ki te pūmua anticoagulation e kiia nei ko "te aukati ara o te kikokiko" me te whakaiti i tana mahi anticoagulation ma reira ka piki ake te nui o te thrombin.
Ko te rongoa hou e whakarato ana i tetahi waahanga maimoatanga hou ki nga turoro. Ko tenei te maimoatanga tuatahi, kore take me te kotahi-wiki mo te hemophilia B.
Ko te whakaaetanga a te FDA ki a Hympavzi i ahu mai i nga hua pai mai i te wahanga 3 o nga whakamatautau haumanu o te pokapū maha i arotakehia tona haumaru me te whaihua ki nga taiohi me nga pakeke kaiuru mai i te 12 ki te <75 tau ki te mate hemophilia nui A, he ahua kino ki te mate hemophilia B ranei.
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Rauemi:
- Ko te tuku korero a te FDA - Ka whakaaetia e te FDA te maimoatanga hou mo te Hemophilia A, B ranei. I tukuna i te 11 Oketopa 2024. Kei te waatea i https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-hemophilia-or-b
- EMA. Hympavzi – Marstacimab. Kei te waatea i https://www.ema.europa.eu/en/medicines/human/EPAR/hympavzi
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