Nge-11 ka-Okthobha ka-2024, i-Hympavzi (marstacimab-hncq), i-antibody ye-monoclonal ejolise "kwi-tissue factor pathway inhibitor" yafumana i-US. FDAUkwamkelwa njengechiza elitsha lothintelo lweziganeko zokopha kubantu abane-hemophilia A okanye i-hemophilia B.
Kwangoko, nge-19 kaSeptemba 2024, iHympavzi yanikwa isigunyaziso sentengiso yi-European Medicine Agency (EMA) yokuthintela ukopha kwizigulana ezine-hemophilia A okanye i-B.
I-Hemophilia A sisifo sokopha esizuzwa njengelifa esibangelwa kukunqongophala kwe-clotting factor VIII ngelixa i-hemophilia B ibangelwa kukungoneli kwe-clotting factor IX. Zombini ezi meko zinyangwa ngokwesiqhelo ngokutshintshwa kweemeko zokujika kwegazi ezilahlekileyo ngeenaliti.
I-Hympavzi ikhusela iziqephu zokopha ngenkqubo eyahlukileyo. Ijolise kwiprotheni ye-anticoagulation eyenziwa ngokwemvelo ebizwa ngokuba yi-"tissue factor pathway inhibitor" kwaye inciphisa umsebenzi wayo we-anticoagulation ngaloo ndlela inyusa inani le-thrombin.
Ichiza elitsha libonelela ngonyango olutsha olunokukhethwa kwizigulana. Olu lolokuqala, olungeyonto yonyango kunye nonyango lwe-hemophilia B kanye ngeveki.
Imvume ye-FDA ye-Hympavzi isekwe kwiziphumo ezanelisayo ezivela kwisigaba sesi-3 solingo lwezonyango oluvavanya ukhuseleko lwalo kunye nokusebenza kwalo kulutsha kunye nabathathi-nxaxheba abadala abaneminyaka eyi-12 ukuya <75 iminyaka kunye ne-hemophilia A emandundu okanye iqatha ngokuphakathi ukuya kwi-hemophilia eqatha B.
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Imithombo:
- Ukukhutshwa kweNdaba ze-FDA – i-FDA iVuma unyango olutsha lwe-Hemophilia A okanye i-B. Ithunyelwe ngomhla we-11 ku-Okthobha 2024. Ifumaneka e- https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-hemophilia-or-b
- EMA. Hympavzi – Marstacimab. Ifumaneka e https://www.ema.europa.eu/en/medicines/human/EPAR/hympavzi
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