Xov xwm

Xinhua | Hloov tshiab: 2020-11-11 09:20

DUAB NTAWV: Lub logo Eli Lilly tau pom ntawm ib lub chaw ua haujlwm ntawm lub tuam txhab hauv San Diego, California, Tebchaws Meskas, Cuaj Hlis 17, 2020. [Duab/Cov Chaw Haujlwm]
WASHINGTON — Lub Chaw Saib Xyuas Khoom Noj thiab Tshuaj ntawm Tebchaws Meskas tau tshaj tawm kev tso cai siv thaum muaj xwm txheej ceev (EUA) rau tus kws tsim tshuaj Asmeskas Eli Lilly txoj kev kho mob monoclonal antibody los kho COVID-19 me me mus rau nruab nrab rau cov neeg laus thiab cov menyuam yaus.

Cov tshuaj, bamlanivimab, tau tso cai rauCov neeg mob COVID-19cov neeg uas muaj hnub nyoog 12 xyoos thiab laus dua uas hnyav tsawg kawg yog 40 kilograms, thiab cov neeg uas muaj feem yuav kis tus kab mob COVID-19 hnyav thiab (lossis) pw hauv tsev kho mob, raws li daim ntawv tshaj tawm ntawm FDA rau hnub Monday.

Qhov no suav nrog cov neeg uas muaj hnub nyoog 65 xyoo lossis laus dua, lossis cov neeg uas muaj qee yam mob ntev.

Cov tshuaj monoclonal antibodies yog cov protein ua hauv chav kuaj uas ua raws li lub cev tiv thaiv kab mob lub peev xwm los tawm tsam cov antigens phem xws li cov kab mob. Bamlanivimab yog ib qho monoclonal antibody uas yog tshwj xeeb tawm tsam cov protein spike ntawm SARS-CoV-2, tsim los thaiv cov kab mob txuas thiab nkag mus rau hauv tib neeg lub hlwb.

Txawm hais tias kev nyab xeeb thiab kev ua tau zoo ntawm kev kho mob tshawb nrhiav no tseem raug soj ntsuam, bamlanivimab tau pom hauv kev sim tshuaj kom txo qis kev mus pw hauv tsev kho mob lossis chav kho mob ceev (ER) rau cov neeg mob uas muaj feem yuav mob hnyav hauv 28 hnub tom qab kev kho mob piv rau placebo, FDA tau hais.

Cov ntaub ntawv txhawb nqa EUA rau bamlanivimab yog raws li kev tshuaj xyuas ib ntus los ntawm theem ob randomized, ob chav dig muag, placebo-tswj kev sim tshuaj hauv 465 tus neeg laus uas tsis tau pw hauv tsev kho mob uas muaj cov tsos mob COVID-19 me me mus rau nruab nrab.

Ntawm cov neeg mob no, 101 tau txais tshuaj bamlanivimab 700-milligram, 107 tau txais tshuaj 2,800-milligram, 101 tau txais tshuaj 7,000-milligram thiab 156 tau txais tshuaj placebo hauv peb hnub tom qab tau txais cov qauv kuaj mob rau thawj qhov kev kuaj mob SARS-CoV-2 zoo.

Rau cov neeg mob uas muaj feem yuav mob hnyav zuj zus, kev mus pw hauv tsev kho mob thiab mus ntsib chav kho mob ceev (ER) tau tshwm sim rau 3 feem pua ​​​​​​ntawm cov neeg mob uas tau kho bamlanivimab piv rau 10 feem pua ​​​​​​ntawm cov neeg mob uas tau kho placebo.

Raws li FDA, cov teebmeem ntawm kev kis tus kab mob thiab kev txo qis kev pw hauv tsev kho mob thiab kev mus ntsib ER, thiab kev nyab xeeb, zoo ib yam li cov neeg mob uas tau txais ib qho ntawm peb koob tshuaj bamlanivimab.

EUA tso cai rau bamlanivimab faib thiab muab tshuaj ib zaug xwb los ntawm cov kws kho mob.

"FDA txoj kev tso cai thaum muaj xwm txheej ceev ntawm bamlanivimab muab rau cov kws kho mob nyob rau pem hauv ntej ntawm tus kab mob sib kis no nrog lwm lub cuab yeej siv tau los kho cov neeg mob COVID-19," Patrizia Cavazzoni, tus thawj coj ua haujlwm ntawm FDA's Center for Drug Evaluation and Research tau hais. "Peb yuav txuas ntxiv mus soj ntsuam cov ntaub ntawv tshiab txog kev nyab xeeb thiab kev ua tau zoo ntawm bamlanivimab thaum lawv muaj."

Raws li kev tshuaj xyuas tag nrho cov pov thawj kev tshawb fawb muaj, FDA tau txiav txim siab tias nws yog qhov tsim nyog los ntseeg tias bamlanivimab yuav ua tau zoo rau kev kho cov neeg mob uas tsis tau pw hauv tsev kho mob uas muaj COVID-19 me me lossis nruab nrab. Thiab, thaum siv los kho COVID-19 rau cov pej xeem uas tau tso cai, cov txiaj ntsig paub thiab muaj peev xwm ntau dua li cov kev pheej hmoo paub thiab muaj peev xwm rau cov tshuaj, raws li FDA.

Raws li lub koom haum, tej zaum yuav muaj cov kev mob tshwm sim ntawm bamlanivimab suav nrog anaphylaxis thiab cov tshuaj tiv thaiv kab mob, xeev siab, raws plab, kiv taub hau, mob taub hau, khaus thiab ntuav.

EUA tau tuaj thaum Tebchaws Meskas tau tshaj 10 lab tus neeg mob COVID-19 hnub Monday, tsuas yog 10 hnub tom qab ncav cuag 9 lab. Tus lej nruab nrab ntawm cov neeg mob tshiab txhua hnub tsis ntev los no tau tshaj 100,000, thiab cov kws tshaj lij kev noj qab haus huv pej xeem tau ceeb toom tias lub tebchaws tab tom nkag mus rau theem phem tshaj plaws ntawm kev sib kis.