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Xinhua | Kubuyekeziwe: 2020-11-11 09:20

IZITHOMBE ZESIFAZANE: Ilogo ka-Eli Lilly iboniswa kwelinye lamahhovisi enkampani e-San Diego, California, US, Septhemba 17, 2020. [Isithombe/Ama-Ejensi]
WASHINGTON - I-US Food and Drug Administration ikhiphe ukugunyazwa kokusetshenziswa kwezimo eziphuthumayo (i-EUA) komkhiqizi wezidakamizwa waseMelika u-Eli Lilly's monoclonal antibody therapy ukwelapha i-COVID-19 ephakathi nendawo ezigulini ezikhulile nezezingane.

Umuthi, bamlanivimab, ugunyaziweIziguli ze-COVID-19abaneminyaka engu-12 nangaphezulu abanesisindo esingamakhilogremu angama-40, futhi abasengozini enkulu yokudlulela ku-COVID-19 kanye (noma) nokulaliswa esibhedlela, ngokusho kwesitatimende se-FDA ngoMsombuluko.

Lokhu kubandakanya labo abaneminyaka engu-65 ubudala noma ngaphezulu, noma abanezimo ezithile zezempilo ezingelapheki.

Amasosha omzimba e-Monoclonal angamaprotheni enziwe elabhorethri alingisa amandla amasosha omzimba okulwa nama-antigen ayingozi njengamagciwane. I-Bamlanivimab iyi-monoclonal antibody eqondiswe ngqo kuphrotheni ye-spike ye-SARS-CoV-2, eklanyelwe ukuvimba okunamathiselwe kwegciwane nokungena kumaseli womuntu.

Ngenkathi ukuphepha nokusebenza ngempumelelo kwalokhu kwelashwa kophenyo kusaqhubeka nokuhlolwa, i-bamlanivimab ikhonjiswe ovivinyweni lomtholampilo ukuze kuncishiswe ukulaliswa esibhedlela okuhlobene ne-COVID-19 noma egumbini lezimo eziphuthumayo (ER) ezigulini ezisengozini enkulu yokuqhubekela phambili kwesifo phakathi kwezinsuku ezingama-28 ngemuva kokwelashwa uma kuqhathaniswa. ku-placebo, kusho i-FDA.

Imininingwane esekela i-EUA ye-bamlanivimab isuselwe ekuhlaziyweni kwesikhashana okuvela esigabeni sesibili esivivinyweni somtholampilo esingahleliwe, esingaboni kabili, esilawulwa yi-placebo kubantu abadala abangalaliswa esibhedlela abangama-465 abanezimpawu ezithambile kuya kwezilinganiselwe ze-COVID-19.

Kulezi ziguli, eziyi-101 zathola umthamo we-700-milligram we-bamlanivimab, eziyi-107 zithole umthamo ongu-2,800-milligram, eziyi-101 zathola umthamo ongu-7,000-milligram kwathi eziyi-156 zathola i-placebo phakathi nezinsuku ezintathu zokuthola isampula lomtholampilo lokuqala eline-SARS-CoV- 2 ukuhlolwa kwegciwane.

Ezigulini ezisengozini enkulu yokuqhubekela phambili kwesifo, ukulaliswa esibhedlela kanye negumbi eliphuthumayo (ER) ukuvakashelwa kwenzeka kumaphesenti angu-3 weziguli eziphathwe nge-bamlanivimab ngokwesilinganiso uma kuqhathaniswa namaphesenti angu-10 ezigulini eziphathwe nge-placebo.

Imiphumela kumthamo wegciwane egazini kanye nokunciphisa ukulaliswa esibhedlela kanye nokuvakasha kwe-ER, kanye nokuphepha, kwakufana ezigulini ezithola noma yimiphi imithamo emithathu ye-bamlanivimab, ngokusho kwe-FDA.

I-EUA ivumela ukuthi i-bamlanivimab isatshalaliswe futhi ilawulwe njengomthamo owodwa ngokufakwa emithanjeni ngabahlinzeki bezempilo.

"Ukugunyazwa okuphuthumayo kwe-FDA kwe-bamlanivimab kunikeza ochwepheshe bezokunakekelwa kwezempilo abaphambili balolu bhubhane ngelinye ithuluzi ekwelapheni iziguli ze-COVID-19," kusho uPatrizia Cavazzoni, umqondisi osabambile we-FDA's Center for Drug Evaluation and Research. "Sizoqhubeka nokuhlola idatha emisha ngokuphepha nokusebenza kwe-bamlanivimab njengoba isitholakala."

Ngokusekelwe ekubuyekezweni kwengqikithi yobufakazi besayensi obutholakalayo, i-FDA inqume ukuthi kunengqondo ukukholelwa ukuthi i-bamlanivimab ingase isebenze ekwelapheni iziguli ezingalaliswa esibhedlela nge-COVID-19 emnene noma emaphakathi. Futhi, lapho isetshenziselwa ukwelapha i-COVID-19 kubantu abagunyaziwe, izinzuzo ezaziwayo nezingaba khona zidlula ubungozi obaziwayo nobungase bube khona bomuthi, ngokusho kwe-FDA.

Imiphumela emibi engaba khona ye-bamlanivimab ihlanganisa i-anaphylaxis kanye nokusabela okuhlobene nokumnika, isicanucanu, isifo sohudo, isiyezi, ikhanda elibuhlungu, ukulunywa nokuhlanza, ngokusho kwe-ejensi.

I-EUA yeza njengoba i-United States idlula amacala ayi-10 e-COVID-19 ngoMsombuluko, ezinsukwini eziyi-10 nje ngemuva kokushaya izigidi eziyi-9. Isibalo sakamuva esimaphakathi sokutheleleka okusha kwansuku zonke sidlule ku-100,000, kanti ochwepheshe bezempilo yomphakathi baxwayise ngokuthi izwe lingena esigabeni esibi kakhulu salolu bhubhane.