Concizumab (Alhemo) fun Hemophilia A tabi B pẹlu awọn inhibitors

Concizumab (orukọ iṣowo, Alhemo), antibody monoclonal ti fọwọsi nipasẹ FDA lori 20 Kejìlá 2024 fun idena awọn iṣẹlẹ ẹjẹ ni awọn alaisan ti o ni hemophilia A pẹlu awọn inhibitors VIII ifosiwewe tabi hemophilia B pẹlu awọn inhibitors IX ifosiwewe. O ti gba ifọwọsi nipasẹ Ile-iṣẹ Oogun Yuroopu (EMA) ni awọn ọjọ diẹ sẹhin ni ọjọ 16 Oṣu kejila ọdun 2024 fun awọn itọkasi kanna.  

Diẹ ninu awọn alaisan haemophilia lori “awọn oogun ifosiwewe didi” fun itọju ipo rudurudu ẹjẹ wọn ṣe agbekalẹ awọn aporo ara (lodi si awọn oogun ifosiwewe didi). Awọn apo-ara ti a ṣẹda ṣe idiwọ iṣe ti “awọn oogun ifosiwewe didi” ti o jẹ ki wọn ko munadoko. Ipo yii ni itọju lọwọlọwọ nipasẹ fifamọra ifarada ajẹsara nipasẹ awọn abẹrẹ ojoojumọ ti awọn ifosiwewe didi. Ifọwọsi ti Concizumab (Alhemo) pese iru awọn alaisan pẹlu itọju miiran.  

A nṣakoso Concizumab lojoojumọ gẹgẹbi abẹrẹ abẹ-ara.  

Ifọwọsi Alhemo da lori igbelewọn aabo ati imunadoko rẹ ni orilẹ-ede pupọ, aarin-pupọ, aami-ìmọ, idanwo ile-iwosan alakoso 3. Ninu idanwo naa, awọn oṣuwọn ẹjẹ ti o sọdọọdun (ABR) ti dinku nipasẹ 86% fun ẹgbẹ itọju Alhemo ni akawe si ẹgbẹ ti ko si prophylaxis.  

Awọn rudurudu ẹjẹ ni haemophilia jẹ nitori aipe awọn ifosiwewe didi. Haemophilia A jẹ nitori aipe ifosiwewe didi VIII, lakoko ti haemophilia B jẹ nitori awọn ipele kekere ti ifosiwewe IX. Aini ifosiwewe iṣẹ-ṣiṣe XI jẹ iduro fun haemophilia C. Awọn ipo wọnyi ni a ṣe itọju nipasẹ fifisilẹ ifosiwewe didi ti a pese sile ni iṣowo tabi ọja ti kii ṣe ifosiwewe bi rirọpo iṣẹ ṣiṣe ti ifosiwewe ti o padanu.  

Octocog alfa (Advate), eyiti o jẹ ‘ẹda apilẹṣẹ nipa lilo imọ-ẹrọ DNA’ ẹya ti didi ifosiwewe VIII, ni a lo nigbagbogbo fun idena ati itọju ibeere ti haemophilia A. Fun haemophilia B, nonacog alfa (BeneFix), eyiti jẹ ẹya ẹlẹrọ version of didi ifosiwewe IX ti wa ni commonly lo.  

Hympavzi (marstacimab-hncq), antibody monoclonal eniyan ti o fojusi “oludana ipa ọna tissue factor” ti fọwọsi laipẹ bi oogun tuntun fun idena awọn iṣẹlẹ ẹjẹ ni awọn ẹni-kọọkan pẹlu hemophilia A tabi hemophilia B.   

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To jo:  

1. FDA fọwọsi oogun lati ṣe idiwọ tabi dinku igbohunsafẹfẹ ti awọn iṣẹlẹ ẹjẹ fun awọn alaisan ti o ni hemophilia A pẹlu awọn inhibitors tabi hemophilia B pẹlu awọn inhibitors. Ti firanṣẹ 20 Oṣu kejila 2024. Wa ni https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-drug-prevent-or-reduce-frequency-bleeding-episodes-patients-hemophilia-inhibitors-or 

2. EMA. Alhemo - Concizumab. Wa https://www.ema.europa.eu/en/medicines/human/EPAR/alhemo ati https://ec.europa.eu/health/documents/community-register/html/h1881.htm  

3. NHS. Itọju Hemophilia. Wa ni https://www.nhs.uk/conditions/haemophilia/treatment/ 

4. ÀJỌ CDC. Itọju Hemophilia. Wa ni  https://www.cdc.gov/hemophilia/treatment/index.html 

Jẹmọ nkan 

• Hympavzi (marstacimab): Itọju Tuntun fun Hemophilia. European ijinle sayensi. Ti a fiweranṣẹ 12 Oṣu Kẹwa 2024. Wa ni http://scientificeuropean.co.uk/medicine/hympavzi-marstacimab-new-treatment-for-hemophilia/ 

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