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IXinhua | Ihlaziyiwe: 2020-11-11 09:20

IFOTO YEFAYILE: Ilogo ka-Eli Lilly iboniswe kwenye yeeofisi zenkampani eSan Diego, eCalifornia, e-US, nge-17 kaSeptemba 2020. [Ifoto/Iiarhente]
IWASHINGTON — I-US Food and Drug Administration ikhuphe imvume yokusetyenziswa ngokukhawuleza (i-EUA) yonyango lwe-monoclonal antibody lomenzi wamayeza waseMelika u-Eli Lilly ukunyanga i-COVID-19 ethambileyo ukuya kwephakathi kwizigulana zabantu abadala nabantwana.

Eli yeza, i-bamlanivimab, ligunyazisiweIzigulane ze-COVID-19abaneminyaka eli-12 nangaphezulu abanobunzima obuyi-40 yeekhilogram, kwaye abasengozini enkulu yokufikelela kwi-COVID-19 enzima kunye (okanye) nokulaliswa esibhedlele, ngokutsho kwengxelo ye-FDA ngoMvulo.

Oku kuquka abo baneminyaka engama-65 ubudala nangaphezulu, okanye abaneengxaki ezithile zempilo ezingapheliyo.

Ii-antibodies ze-Monoclonal ziiproteni ezenziwe elebhu ezilinganisa amandla omzimba okulwa nee-antigens eziyingozi ezifana neentsholongwane. I-Bamlanivimab yi-antibody ye-monoclonal ejoliswe ngokukodwa kwi-spike protein ye-SARS-CoV-2, eyenzelwe ukuthintela ukunamathela kwentsholongwane kunye nokungena kwayo kwiiseli zomntu.

Nangona ukhuseleko kunye nokusebenza kakuhle kolu nyango lophando kusaqhubeka kuvavanywa, i-bamlanivimab iboniswe kwizilingo zeklinikhi ukunciphisa ukulaliswa esibhedlele okunxulumene ne-COVID-19 okanye ukutyelela kwigumbi likaxakeka (ER) kwizigulana ezisengozini enkulu yokuqhubela phambili kwesifo kwiintsuku ezingama-28 emva konyango xa kuthelekiswa ne-placebo, itsho i-FDA.

Idatha exhasa i-EUA ye-bamlanivimab isekelwe kuhlalutyo lwexeshana oluvela kwisigaba sesibini sovavanyo lweklinikhi olulawulwa ngokungacwangciswanga, olungaboni kabini, olulawulwa yi-placebo kubantu abadala abangama-465 abangalaliswanga esibhedlele abaneempawu ze-COVID-19 eziphantsi ukuya kweziphakathi.

Kwezi zigulana, ezili-101 zafumana idosi ye-bamlanivimab engama-700-milligram, ezili-107 zafumana idosi ye-2,800-milligram, ezili-101 zafumana idosi ye-7,000-milligram kwaye ezili-156 zafumana i-placebo kwiintsuku ezintathu emva kokufumana isampuli yeklinikhi yovavanyo lokuqala lwe-SARS-CoV-2 olunentsholongwane.

Kwizigulane ezisengozini enkulu yokuqhubela phambili kwesifo, ukulaliswa esibhedlele kunye nokutyelela kwigumbi likaxakeka (ER) kwenzeke kwi-3 ekhulwini yezigulane ezinyangwe yi-bamlanivimab ngokomyinge xa ​​kuthelekiswa ne-10 ekhulwini kwizigulane ezinyangwe yi-placebo.

Imiphumo kumthwalo wentsholongwane kunye nokunciphisa ukulaliswa esibhedlele kunye nokutyelela i-ER, kunye nokhuseleko, yayifana kwizigulana ezifumana nayiphi na idosi ezintathu ze-bamlanivimab, ngokutsho kwe-FDA.

I-EUA ivumela ukuba i-bamlanivimab isasazwe kwaye inikwe njengedosi enye ngemithambo yegazi ngababoneleli beenkonzo zempilo.

“Imvume engxamisekileyo ye-FDA ye-bamlanivimab inika iingcali zezempilo ezikwicala eliphambili lo bhubhane esinye isixhobo esinokwenzeka ekunyangeni izigulane ze-COVID-19,” utshilo uPatrizia Cavazzoni, umlawuli obambeleyo weZiko loVavanyo lwaMayeza kunye noPhando lwe-FDA. “Siza kuqhubeka nokuvavanya idatha entsha malunga nokhuseleko kunye nokusebenza kakuhle kwe-bamlanivimab njengoko ifumaneka.”

Ngokusekelwe kuphononongo lobungqina besayensi obupheleleyo obufumanekayo, i-FDA igqibe kwelokuba kusengqiqweni ukukholelwa ukuba i-bamlanivimab inokuba luncedo ekunyangeni izigulane ezingalaliswanga esibhedlele ezine-COVID-19 encinci okanye ephakathi. Kwaye, xa isetyenziselwa ukunyanga i-COVID-19 kubantu abagunyazisiweyo, iingenelo ezaziwayo nezinokubakho zingaphezulu kweengozi ezaziwayo nezinokubakho zeli yeza, ngokutsho kwe-FDA.

Iziphumo ebezingalindelekanga ze-bamlanivimab ziquka i-anaphylaxis kunye neempendulo ezinxulumene nokufakwa kwe-infusion, isicaphucaphu, urhudo, isiyezi, intloko ebuhlungu, ukurhawuzelelwa kunye nokuhlanza, ngokutsho kwe-arhente.

I-EUA ifike njengoko i-United States idlule kwi-10 yezigidi ze-COVID-19 ngoMvulo, kwiintsuku nje ezili-10 emva kokuba ifikelele kwi-9 yezigidi. Inani eliqhelekileyo lakutshanje losulelo olutsha lwemihla ngemihla lidlule kwi-100,000, kwaye iingcali zempilo yoluntu zilumkisile ukuba ilizwe lingena kwinqanaba elibi kakhulu lobhubhane.