Concizumab (igama lentengiso, Alhemo), i-antibody ye-monoclonal yavunywa yi-FDA ngomhla we-20 kuDisemba 2024 ukuthintela iziqephu ezophayo kwizigulane ezine-hemophilia A ene-factor VIII inhibitors okanye i-hemophilia B ene-factor IX inhibitors. Yayifumene imvume yi-Arhente ye-European Medicines Agency (EMA) kwiintsuku ezimbalwa ezidlulileyo kwi-16 kaDisemba 2024 ngezibonakaliso ezifanayo.
Ezinye izigulana ezinehaemophilia “kumayeza ee-clotting factor” kunyango lwemeko yazo yokopha ziye ziphuhlise izilwa-buhlungu (ezichasene namayeza e-clotting factor). Izilwa-buhlungu ezenziweyo zithintela isenzo “samayeza ee-clotting factor” ziwenza angasebenzi kakuhle. Le meko okwangoku iphathwa ngokunyamezelwa kwamajoni omzimba ngokusebenzisa iinaliti zemihla ngemihla zezinto zokujiyisa. Ukuvunywa kweConcizumab (Alhemo) kunika izigulane ezinjalo ngolunye unyango.
I-Concizumab isetyenziswa yonke imihla njengenaliti engaphantsi kwesikhumba.
Ukuvunywa kwe-Alhemo kwakusekelwe ekuvavanyeni ukhuseleko lwayo kunye nokusebenza kwi-multi-national, multi-centre, open-label, isigaba se-3 solingo lwezonyango. Kulingo, amazinga okuphuma kwegazi ngonyaka (ABR) ancitshiswe ngama-86% kwiqela lonyango lwe-Alhemo xa kuthelekiswa neqela le-prophylaxis.
Iziphazamiso zokopha kwi-haemophilia zibangelwa kukunganeli kwezinto zokujiyisa. IHaemophilia A yenziwa ngenxa yokunqongophala kwe-clotting factor VIII, ngelixa i-haemophilia B ibangelwa kumanqanaba aphantsi e-factor IX. Ukunqongophala kwe-Factor factor XI inoxanduva lwe-haemophilia C. Ezi meko zinyangwa ngokufafaza i-clotting factor elungiselelwe urhwebo okanye i-non-factor product njenge-active replacement of the missing factor.
I-Octocog alfa (Advate), 'eyenziwe ngokwemfuza kusetyenziswa ubuchwepheshe be-DNA' inguqulelo ye-clotting factor VIII, idla ngokusetyenziselwa uthintelo kunye nonyango oluyimfuneko lwehaemophilia A. Kwi-haemophilia B, nonacog alfa (BeneFix), ethi luluguqulelo lobunjineli lwe-clotting factor IX eqhele ukusetyenziswa.
IHympavzi (marstacimab-hncq), i-antibody ye-monoclonal yomntu ejolise kwi-"tissue factor pathway inhibitor" isandula kuvunywa njengechiza elitsha lokuthintela iziqendu zokopha kubantu abane-hemophilia A okanye i-hemophilia B.
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Iingxelo:
- I-FDA iyalivuma iyeza lokuthintela okanye lokunciphisa ukuphindaphindeka kweziganeko ukopha kwizigulane ezine-hemophilia A ene-inhibitors okanye i-hemophilia B ene-inhibitors. Ithunyelwe nge-20 kuDisemba 2024. Ifumaneka apha https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-drug-prevent-or-reduce-frequency-bleeding-episodes-patients-hemophilia-inhibitors-or
- EMA. Alhemo – Concizumab. Iyafumaneka https://www.ema.europa.eu/en/medicines/human/EPAR/alhemo kwaye https://ec.europa.eu/health/documents/community-register/html/h1881.htm
- I-NHS. Unyango lwe-Hemophilia. Ifumaneka e https://www.nhs.uk/conditions/haemophilia/treatment/
- I-CDC. Unyango lwe-Hemophilia. Ifumaneka e https://www.cdc.gov/hemophilia/treatment/index.html
Inqaku elinxulumene nalo
- I-Hympavzi (marstacimab): Unyango olutsha lwe-Hemophilia. Inzululwazi yaseYurophu. Ithunyelwe nge-12 ka-Okthobha 2024. Iyafumaneka e https://www.scientificeuropean.co.uk/medicine/hympavzi-marstacimab-new-treatment-for-hemophilia/
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