Nkhani

Xinhua | Kusinthidwa: 11/11/2020 09:20

ZITHUNZI ZABWINO: Chizindikiro cha Eli Lilly chikuwonetsedwa pa ofesi ina yamakampani ku San Diego, California, US, pa Seputembara 17, 2020. [Chithunzi/Mabungwe]
WASHINGTON - US Food and Drug Administration yapereka chilolezo chogwiritsa ntchito mwadzidzidzi (EUA) kwa wopanga mankhwala waku America Eli Lilly's monoclonal antibody therapy kuchiza COVID-19 wofatsa mpaka wocheperako mwa odwala akulu ndi ana.

Mankhwala, bamlanivimab, amaloledwaOdwala a COVID-19omwe ali ndi zaka 12 kapena kuposerapo akulemera pafupifupi ma kilogalamu 40, ndipo omwe ali pachiwopsezo chachikulu chokhala ndi COVID-19 komanso (kapena) kuchipatala, malinga ndi zomwe FDA idanena Lolemba.

Izi zikuphatikizapo omwe ali ndi zaka 65 kapena kuposerapo, kapena omwe ali ndi matenda aakulu.

Ma antibodies a monoclonal ndi mapuloteni opangidwa ndi labotale omwe amatsanzira mphamvu ya chitetezo cha mthupi kulimbana ndi ma antigen owopsa monga ma virus. Bamlanivimab ndi anti-monoclonal antibody yomwe imawongoleredwa motsutsana ndi mapuloteni a spike a SARS-CoV-2, opangidwa kuti aletse kulumikizidwa kwa kachilomboka ndikulowa m'maselo amunthu.

Ngakhale chitetezo ndi mphamvu ya chithandizo chofufuzirachi chikupitilira kuunikiridwa, bamlanivimab adawonetsedwa m'mayesero azachipatala kuti achepetse kuyendera chipatala chokhudzana ndi COVID-19 kapena chipinda chadzidzidzi (ER) kwa odwala omwe ali pachiwopsezo chachikulu cha matenda mkati mwa masiku 28 atalandira chithandizo poyerekeza. ku placebo, adatero FDA.

Zambiri zomwe zimathandizira EUA ya bamlanivimab zachokera pakuwunika kwakanthawi kuchokera mugawo lachiwiri, lopanda khungu, loyang'aniridwa ndi placebo mwa akulu 465 omwe sanagoneke m'chipatala omwe ali ndi zizindikiro zochepa za COVID-19.

Mwa odwalawa, 101 adalandira mlingo wa 700-milligram wa bamlanivimab, 107 adalandira mlingo wa 2,800-milligram, 101 adalandira mlingo wa 7,000-milligram ndipo 156 adalandira placebo mkati mwa masiku atatu atapeza chitsanzo chachipatala cha SARS-CoV- 2 ma virus.

Kwa odwala omwe ali pachiopsezo chachikulu cha matenda, zipatala ndi chipinda chodzidzimutsa (ER) kuyendera kunachitika mu 3 peresenti ya odwala omwe amachiritsidwa ndi bamlanivimab pafupifupi poyerekeza ndi 10 peresenti ya odwala omwe amachiritsidwa ndi placebo.

Zotsatira za kuchuluka kwa ma virus komanso kuchepa kwa zipatala ndi maulendo a ER, komanso pachitetezo, zinali zofanana ndi odwala omwe amalandila mlingo uliwonse mwa atatu amlanivimab, malinga ndi FDA.

EUA imalola kuti bamlanivimab igawidwe ndi kuperekedwa ngati mlingo umodzi m'mitsempha ndi opereka chithandizo chamankhwala.

"Chilolezo chadzidzidzi cha FDA cha bamlanivimab chimapatsa akatswiri azaumoyo kutsogolo kwa mliriwu chida china chothandizira odwala a COVID-19," atero a Patrizia Cavazzoni, wotsogolera wamkulu wa FDA's Center for Drug Evaluation and Research. "Tipitiliza kuwunika zatsopano zokhudzana ndi chitetezo ndi mphamvu ya bamlanivimab ikapezeka."

Kutengera kuwunika kwa umboni wonse wasayansi womwe ulipo, a FDA adatsimikiza kuti ndizomveka kukhulupirira kuti bamlanivimab ikhoza kukhala yothandiza pochiza odwala omwe sanagoneke m'chipatala omwe ali ndi COVID-19 wofatsa kapena wocheperako. Ndipo, zikagwiritsidwa ntchito pochiza COVID-19 kwa anthu ovomerezeka, zodziwika komanso zopindulitsa zimaposa zomwe zimadziwika komanso zomwe zingachitike pamankhwalawa, malinga ndi FDA.

Zotsatira zomwe zingatheke za bamlanivimab zimaphatikizapo anaphylaxis ndi kulowetsedwa kokhudzana ndi kulowetsedwa, nseru, kutsegula m'mimba, chizungulire, mutu, kuyabwa ndi kusanza, malinga ndi bungwe.

EUA idabwera pomwe United States idaposa milandu 10 miliyoni ya COVID-19 Lolemba, patangotha ​​​​masiku 10 atagunda 9 miliyoni. Chiwerengero chaposachedwa cha matenda atsopano tsiku lililonse chapitilira 100,000, ndipo akatswiri azaumoyo achenjeza kuti dzikolo likulowa pachiwopsezo chachikulu cha mliri.