Ngomhla ziyi-11 kuMfumfu 2024, i-Hympavzi (marstacimab-hncq), i-antibody ye-monoclonal yomuntu eqondise “i-tissue factor pathway inhibitor” yathola i-US FDAukugunyazwa njengomuthi omusha wokuvimbela iziqephu zokopha kubantu abane-hemophilia A noma i-hemophilia B.
Phambilini, ngomhla ka-19 Septhemba 2024, uHympavzi wanikezwa igunya lokumaketha yi-European Medicine Agency (EMA) ngokuvimbela iziqephu zokopha ezigulini ezine-hemophilia A noma B enzima.
I-Hemophilia A isifo sokopha esitholakala ngofuzo esibangelwa ukuntuleka kwe-clotting factor VIII kuyilapho i-hemophilia B ibangelwa ukuntuleka kwe-clotting factor IX. Zombili lezi zimo ziphathwa ngokujwayelekile ngokushintsha izici zokujiya kwegazi ezingekho ngomjovo.
I-Hympavzi ivimbela iziqephu zokopha ngenqubo ehlukile. Iqondise kuphrotheni eyenzeka ngokwemvelo ye-anticoagulation ebizwa ngokuthi “tissue factor pathway inhibitor” futhi inciphisa umsebenzi wayo we-anticoagulation ngaleyo ndlela ikhulise inani le-thrombin.
Umuthi omusha uhlinzeka ngendlela entsha yokwelashwa ezigulini. Lokhu okokuqala, okungeyona into kanye nokwelashwa kwe-hemophilia B kanye ngesonto.
Ukugunyaza kwe-FDA kwe-Hympavzi kusekelwe emiphumeleni egculisayo evela esivivinyweni semitholampilo sesigaba sesi-3 se-multicentre esihlole ukuphepha nokusebenza kahle kwaso entsheni nakubantu abadala abahlanganyeli abaneminyaka engu-12 kuya kwengu-75 abane-hemophilia A enzima noma i-hemophilia enzima kakhulu ukuya kwenzima kakhulu.
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Imithombo:
- Ukukhishwa Kwezindaba ze-FDA - I-FDA Igunyaza Ukwelashwa Okusha Kwe-Hemophilia A noma B. Kuthunyelwe ngomhla ka-11 Okthoba 2024. Kutholakala e- https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-hemophilia-or-b
- I-EMA. Hympavzi – Marstacimab. Itholakala ngo https://www.ema.europa.eu/en/medicines/human/EPAR/hympavzi
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, a human monoclonal antibody targeting “tissue factor pathway inhibitor” received US FDA’s approval as a new drug for prevention of bleeding episodes in individuals with hemophilia A or hemophilia B. ){kind=link}