Xov xwm

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

COV PHOOJ YWG PHOOJ YWG: Eli Lilly lub logo muaj nyob rau ntawm ib lub tuam txhab chaw ua haujlwm hauv San Diego, California, Asmeskas, Lub Cuaj Hli 17, 2020. [Duab/Cov koom haum]
WASHINGTON - US Food and Drug Administration tau tshaj tawm tsab ntawv tso cai siv thaum muaj xwm txheej ceev (EUA) rau tus kws tsim tshuaj Asmeskas Eli Lilly txoj kev kho mob monoclonal los kho tus mob me-rau-nruab nrab COVID-19 rau cov neeg laus thiab menyuam yaus.

Cov tshuaj, bamlanivimab, tau tso cai rauCov neeg mob COVID-19uas muaj hnub nyoog 12 xyoos thiab laus dua uas hnyav tsawg kawg yog 40 kilograms, thiab leej twg muaj kev pheej hmoo siab rau kev loj hlob mus rau COVID-19 hnyav thiab (lossis) mus pw hauv tsev kho mob, raws li tsab ntawv tshaj tawm ntawm FDA rau hnub Monday.

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

Monoclonal antibodies yog cov khoom siv hauv chaw kuaj mob uas ua rau lub cev tiv thaiv kab mob muaj peev xwm tawm tsam cov kab mob phem xws li kab mob. Bamlanivimab yog ib qho tshuaj tiv thaiv kab mob monoclonal uas tau qhia tshwj xeeb los tiv thaiv cov protein ntau ntawm SARS-CoV-2, tsim los thaiv tus kab mob 'kev txuas thiab nkag mus rau tib neeg lub hlwb.

Thaum qhov kev nyab xeeb thiab kev ua tau zoo ntawm qhov kev tshawb nrhiav kev kho mob tseem raug tshuaj xyuas, bamlanivimab tau pom nyob rau hauv kev sim tshuaj kom txo tau COVID-19 txog kev mus pw hauv tsev kho mob lossis chav kho mob xwm txheej ceev (ER) mus ntsib cov neeg mob uas muaj kev pheej hmoo kis tus kab mob hauv 28 hnub tom qab kev kho mob thaum piv. rau cov placebo, hais tias FDA.

Cov ntaub ntawv txhawb nqa EUA rau bamlanivimab yog ua raws li kev soj ntsuam ib ntus los ntawm theem ob randomized, ob qhov muag tsis pom kev, cov tshuaj placebo-tswj tshuaj nyob rau hauv 465 cov neeg laus uas tsis nyob hauv tsev kho mob uas muaj cov tsos mob me me txog COVID-19.

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

Rau cov neeg mob uas muaj kev pheej hmoo siab rau kev kis kab mob, mus pw hauv tsev kho mob thiab chav kho mob xwm txheej ceev (ER) tau tshwm sim hauv 3 feem pua ​​​​ntawm cov neeg mob kho bamlanivimab nyob rau nruab nrab piv rau 10 feem pua ​​​​ntawm cov neeg mob uas tau txais cov placebo.

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

EUA tso cai rau bamlanivimab faib thiab muab tshuaj raws li ib koob tshuaj txhaj los ntawm cov kws kho mob.

Patrizia Cavazzoni, tus thawj coj ntawm FDA's Center for Drug Evaluation and Research tau hais tias "FDA qhov kev tso cai xwm txheej ceev ntawm bamlanivimab muab cov kws saib xyuas kev noj qab haus huv nyob rau pem hauv ntej ntawm tus kabmob kis no nrog rau lwm cov cuab yeej siv los kho cov neeg mob COVID-19," "Peb tseem yuav tshuaj xyuas cov ntaub ntawv tshiab ntawm kev nyab xeeb thiab kev ua tau zoo ntawm bamlanivimab thaum lawv muaj."

Raws li kev tshuaj xyuas tag nrho ntawm cov pov thawj kev tshawb fawb muaj, FDA tau txiav txim siab tias nws tsim nyog ntseeg tias bamlanivimab tuaj yeem siv tau zoo hauv kev kho cov neeg mob uas tsis nyob hauv tsev kho mob me lossis nruab nrab ntawm COVID-19. Thiab, thaum siv los kho COVID-19 rau cov pej xeem tau tso cai, cov txiaj ntsig paub thiab muaj peev xwm tshaj qhov paub thiab muaj peev xwm txaus ntshai rau cov tshuaj, raws li FDA.

Cov kev phiv tshwm sim ntawm bamlanivimab muaj xws li anaphylaxis thiab infusion-reactions, xeev siab, raws plab, kiv taub hau, mob taub hau, khaus thiab ntuav, raws li lub koom haum.

EUA tuaj raws li Tebchaws Meskas tau tshaj 10 lab tus neeg mob COVID-19 hnub Monday, tsuas yog 10 hnub tom qab tsoo 9 lab. Tsis ntev los no tus naj npawb nruab nrab ntawm cov kab mob tshiab niaj hnub tau tshaj 100,000, thiab cov kws paub txog kev noj qab haus huv rau pej xeem tau ceeb toom tias lub teb chaws tab tom nkag mus rau qhov kis tus kab mob loj tshaj plaws.