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I-Xinhua | Kubuyekezwe: 2020-11-11 09:20

ISITHOMBE SEFAYELA: Ilogo ka-Eli Lilly iboniswa kwelinye lamahhovisi enkampani eSan Diego, eCalifornia, e-US, mhla ziyi-17 kuMandulo 2020. [Isithombe/Ama-ejensi]
WASHINGTON — I-US Food and Drug Administration ikhiphe imvume yokusetshenziswa okuphuthumayo (i-EUA) yokwelashwa kwe-antibody ye-monoclonal yabakhiqizi bemithi baseMelika u-Eli Lilly ukwelapha i-COVID-19 emnene kuya kwephakathi ezigulini zabantu abadala nezingane.

Umuthi, i-bamlanivimab, uvunyelwe ukusetshenziswaIziguli ze-COVID-19abaneminyaka eyi-12 nangaphezulu abanesisindo esingaphansi kwamakhilogremu angama-40, futhi abasengozini enkulu yokudlulela ekubeni yi-COVID-19 embi kakhulu kanye (noma) nokulaliswa esibhedlela, ngokusho kwesitatimende se-FDA ngoMsombuluko.

Lokhu kufaka phakathi labo abaneminyaka engu-65 noma ngaphezulu, noma abanezinkinga ezithile zezempilo ezingamahlalakhona.

Ama-antibodies e-Monoclonal angamaphrotheni enziwe elebhu alingisa ikhono lesimiso somzimba sokuzivikela ekulweni nama-antigen ayingozi njengama-virus. I-Bamlanivimab iyi-antibody ye-monoclonal eqondiswe ngqo kuphrotheni ye-spike ye-SARS-CoV-2, eyenzelwe ukuvimba ukunamathela kwegciwane nokungena kwamangqamuzana omuntu.

Nakuba ukuphepha nokusebenza kahle kwalolu hlobo lokwelapha oluphenywayo kuqhubeka nokuhlolwa, i-bamlanivimab iboniswe ezivivinyweni zemitholampilo ukunciphisa ukulaliswa esibhedlela okuhlobene ne-COVID-19 noma ukuvakashelwa kwamagumbi okuphuthumayo (ER) ezigulini ezisengozini enkulu yokuqhubeka kwesifo zingakapheli izinsuku ezingama-28 ngemuva kokwelashwa uma kuqhathaniswa ne-placebo, kusho i-FDA.

Idatha esekela i-EUA ye-bamlanivimab isekelwe ekuhlaziyweni kwesikhashana okuvela esivivinyweni sezokwelapha sesigaba sesibili esingahleliwe, esingaboni kabili, esilawulwa yi-placebo kubantu abadala abangu-465 abangalaliswanga esibhedlela abanezimpawu ze-COVID-19 ezincane kuya kweziphakathi.

Kulezi ziguli, eziyi-101 zathola umthamo we-bamlanivimab ongu-700-milligram, eziyi-107 zathola umthamo we-2,800-milligram, eziyi-101 zathola umthamo we-7,000-milligram kanti eziyi-156 zathola i-placebo zingakapheli izinsuku ezintathu zithole isampula yomtholampilo yokuhlolwa kokuqala kwegciwane le-SARS-CoV-2.

Ezigulini ezisengozini enkulu yokuqhubeka kwesifo, ukulaliswa esibhedlela kanye nokuvakashelwa kwamagumbi ezimo eziphuthumayo (ER) kwenzeke ngokwesilinganiso kumaphesenti ama-3 ezigulini ezelashwe nge-bamlanivimab uma kuqhathaniswa namaphesenti ayi-10 ezigulini ezelashwe nge-placebo.

Imiphumela kumthamo wegciwane kanye nokwehla kokulaliswa esibhedlela kanye nokuvakasha kwe-ER, kanye nokuphepha, yayifana ezigulini ezithola noma yimiphi imithamo emithathu ye-bamlanivimab, ngokusho kwe-FDA.

I-EUA ivumela ukuthi i-bamlanivimab isatshalaliswe futhi inikezwe njengomthamo owodwa ngemithambo yegazi ngabahlinzeki bezempilo.

“Ukugunyazwa okuphuthumayo kwe-FDA kwe-bamlanivimab kunikeza ochwepheshe bezempilo abaphambili kulolu bhubhane elinye ithuluzi elingase libe khona ekwelapheni iziguli ze-COVID-19,” kusho uPatrizia Cavazzoni, umqondisi ophethe we-FDA's Center for Drug Evaluation and Research. “Sizoqhubeka nokuhlola idatha emisha ngokuphepha nokusebenza kahle kwe-bamlanivimab njengoba itholakala.”

Ngokusekelwe ekubuyekezweni kobufakazi besayensi obukhona, i-FDA inqume ukuthi kunengqondo ukukholelwa ukuthi i-bamlanivimab ingaba wusizo ekwelapheni iziguli ezingalaliswanga esibhedlela ezine-COVID-19 emnene noma ephakathi. Futhi, uma isetshenziswa ukwelapha i-COVID-19 kubantu abagunyaziwe, izinzuzo ezaziwayo nezingaba khona zidlula izingozi ezaziwayo nezingaba khona zomuthi, ngokusho kwe-FDA.

Imiphumela emibi engaba khona ye-bamlanivimab ihlanganisa i-anaphylaxis kanye nokusabela okuhlobene nokufakwa kwesidakamizwa, isicanucanu, uhudo, isiyezi, ikhanda elibuhlungu, ukulunywa kanye nokuhlanza, ngokusho kwenhlangano.

I-EUA ize njengoba i-United States idlule amacala e-COVID-19 ayizigidi eziyi-10 ngoMsombuluko, ezinsukwini eziyi-10 nje kuphela ngemuva kokufinyelela ku-9 million. Inani elimaphakathi lamuva nje lokutheleleka okusha kwansuku zonke lidlule ku-100,000, futhi ochwepheshe bezempilo yomphakathi baxwayise ngokuthi izwe lingena esigabeni esibi kakhulu sobhubhane.