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I-XINHUA | Kuvuselelwe: 2020-11-11 09:20

Ifayela Lesithombe: I-Logo Lilly Logo iboniswa kwelinye lamahhovisi enkampani eSan Diego, California, US, Septhemba 17, 2020. [Izithombe / ama-ejensi]
I-Washington - Ukudla Kwezidakamizwa kanye Nezidakamizwa kukhiphe umthetho wokuhlinzekelwa kwezimo eziphuthumayo (i-EUA) ye-Antilody Drugmaker antilody therapy yokwelapha ukwelashwa kwe-Antibody ka-Antilody ka-American Ulawokulashwa ngokuphatha i-Covid emnene-kuya-19 kweziguli ezindala nezingane.

Lo muthi, uBamlanivimab, ugunyaziweIziguli eziyi-19Obani abaneminyaka eyi-12 ubudala nangaphezulu banesisindo okungenani amakhilogremu angama-40, futhi abasengozini enkulu yokuthuthuka kwi-Covid ye-Covil-19 no (noma), ngokwesitatimende se-FDA ngoMsombuluko.

Lokhu kufaka phakathi labo abaneminyaka engu-65 ubudala noma ngaphezulu, noma abanezimo ezithile zokwelashwa ezingapheli.

Ama-antibodies e-monoclonal amaprotheni enziwa elenziwe ngelabhorethri alingisa amandla okuvikezela amasosha omzimba okulwa nama-antigen ayingozi njengamagciwane. I-Bamlanivimab yi-antibody ye-monoclonal eqondiswe ngokuqondile ngokumelene neprotheni yeSpike ye-SARS-cov-2, yakhelwe ukuvimba okunamathiselwe kwegciwane kanye nokungena kumaseli womuntu.

Ngenkathi ukuphepha kanye nokusebenza kwaloluleki lokuphenya kuqhubeka kuhlolwe, uBamelanivimab wakhonjiswa ezivivinyweni ezihlobene nemitholampilo ukunciphisa iziguli ezihlobene neziguli ezingxabanweni zezifo kungakapheli nokwelashwa uma kuqhathaniswa Ukuze ubeke i-placebo, kusho i-FDA.

Imininingwane exhasa i-EUA yeBamlanivimab isuselwa ekuhlaziyweni kwesikhashana kusuka esigabeni sababili, izimpumputhe ezilawulwa kabili, okulawulwa yi-placebo-elawulwa kahle kubantu abadala abangu-465 esibhedlela abanezimpawu ezimnene zezindawo eziyi-19.

Kulezi ziguli, u-101 wathola umthamo we-bamlanivimab, 107 uthole umthamo we-bamlanivimab, u-107 uthole umthamo we-2 800 milligram, uthole umthamo wama-milligram ayi-7,000 kwathola i-placebo kungakapheli izinsuku ezintathu ukuthola isampula emtholampilo ye-SARS yokuqala ye-SARS-CoV 2 Ukuhlolwa kwegciwane.

Ezigulini ezisengozini enkulu yokuqhubekela phambili kwezifo, ezibhedlela kanye nekamelo lezimo eziphuthumayo (ER) ukuvakasha kwenzeka ngamaphesenti ama-3 eziguli eziphathwayo zeBamlanivimab ngokwesilinganiso kuqhathaniswa namaphesenti ayishumi ezigulini eziyishumi.

Imiphumela emthwalweni wegciwane nangokwephulwa kwezibhedlela nase-ER ukuvakasha esibhedlela, futhi ngokuphepha, kwakufana neziguli ezithola noma yimiphi imithamo emithathu yeBamlanivimab, ngokusho kwe-FDA.

I-EUA ivumela iBamlanivimab ukuthi isatshalaliswe futhi ilawulwe njengethamo elilodwa ngokungenamfihlo ngabahlinzeki bezokunakekelwa kwempilo.

"Ukugunyazwa okuphuthumayo kwe-FDA ye-FDA "Sizoqhubeka nokuhlola idatha entsha ngokuphepha nokusebenza ngempumelelo kweBamlanivimab njengoba betholakala."

Ngokusekelwe ekubuyekezweni kobufakazi besayensi obukhona, i-FDA inqume ukuthi kunengqondo ukukholelwa ukuthi iBamlanivimab ingaphumelela ekwelapheni iziguli ezingezona esibhedlela i-AVID enesibhedlela noma esilinganiselwe se-19. Futhi, lapho kusetshenziselwa ukwelapha i-Covid-19 yabantu abagunyaziwe, izinzuzo ezaziwayo nezingaba khona zidlula izingozi ezaziwayo nezingaba khona zomuthi, ngokusho kwe-FDA.

Imiphumela emibi engenzeka ye-bamlanivimab ifaka phakathi ukuphendula okuhlobene ne-anaphylaxis kanye nokumenyezelwa, isicanucanu, isifo sohudo, isiyezi, ikhanda, ukulunywa kanye nokuhlanza, ngokuya nge-ejensi.

I-EUA yafika njenge-United States idlula amacala ayi-10 ezigidi-eziyi-19 uMsombuluko, ezinsukwini eziyi-10 ngemuva kokushaya izigidi eziyi-9. Inani elijwayelekile lakamuva lezifo ezintsha zansuku zonke lidlule kakhulu ku-100,000, kanti ochwepheshe bezempilo bakahulumeni baye baxwayisa ngokuthi izwe lingena esigabeni esibi kakhulu sikabhubhane.