Asmeskas FDA nthuav dav Incyte/Lilly JAK inhibitor Olumiant (baricitinib) tso cai siv xwm txheej ceev (EUA)!

Tsis ntev los no, Eli Lilly thiab nws tus khub Incyte tau tshaj tawm tias US Food and Drug Administration (FDA) tau nthuav dav kev tso cai siv xwm txheej ceev (EUA) rau qhov ncauj JAK inhibitor Olumiant (baricitinib), tso cai ua ke lossis tsis siv ua keRemdesivirtau siv rau kev kho mob, thaum yav dhau los EUA tau txwv tsis pub siv ua ke nrog remdesivir.

Thaum lub Kaum Ib Hlis 2020, Asmeskas FDA tau tso cai Olumiant EUA: Muab Olumiant nrog Veklury (Remdesivir) rau qhov tsis txaus ntseeg lossis kuaj pom pom tus mob coronavirus mob ntsws tshiab (COVID-19), cov pa oxygen ntxiv/tsis cuam tshuam lossis cuam tshuam lub tshuab ua pa/hauv vitro Membrane ntsws oxygenation (ECMO), cov neeg laus pw hauv tsev kho mob thiab cov menyuam yaus hnub nyoog ≥2 xyoos. EUA pom zoo koob tshuaj yog: Olumiant 4 mg ib hnub ib zaug rau 14 hnub lossis txog thaum tso tawm.

Ilya Yuffa, tus lwm thawj coj laus thiab tus thawj tswj hwm ntawm Eli Lilly Biopharmaceuticals, hais tias:"baricitinibthiab remdesivir tau muab kev kho mob rau ntau tus neeg mob. Raws li kev tso cai siv tam sim no, nws tuaj yeem pab tiv thaiv qee yam COVID-19 cov neeg mob pw hauv tsev kho mob. Kev vam meej mus rau qhov cua lossis tuag, thiab ua kom rov zoo dua. Hnub no FDA ua haujlwm muab cov kws kho mob xaiv kev kho mob txuas ntxiv mus kom tau raws li qhov xav tau kho mob sai sai los ntawm tus kab mob sib kis no. Raws li cov pov thawj ntxiv, peb yogbaricitinibmuaj kev ntseeg siab txog nws lub peev xwm uas yog qhov kev xaiv kho mob tseem ceeb rau COVID-19 cov neeg mob hauv tsev kho mob uas xav tau cov pa oxygen ntxiv."

FDA tau nthuav dav Olumiant EUA raws li cov ntaub ntawv los ntawm Phase 3 COV-BARRIER (NCT04421027) kev kawm rau kev kho mob hauv tsev kho mob COVID-19 cov neeg mob. Cov txiaj ntsig ntawm txoj kev tshawb fawb tau tshaj tawm rau lub Plaub Hlis xyoo no. Cov ntaub ntawv qhia pom tias nyob rau hnub 28, txawm hais tias txoj kev tshawb fawb tsis ua tiav qhov kawg, piv nrog cov placebo + kev saib xyuas tus qauv (SoC, suav nrog corticosteroids thiab remdesivir), Olumiant + tus qauv saib xyuas yuav muaj kev pheej hmoo tuag tau txo los ntawm 39% (p=0.0018).

Olumiant' cov khoom siv tshuaj muaj yees yog baricitinib, uas yog xaiv thiab thim rov qab JAK1 thiab JAK2 inhibitor uas tau hais lus ib zaug ib hnub. Nws yog tam sim no hauv kev kho mob rau kev kho mob ntawm ntau yam kab mob sib kis thiab kab mob autoimmune, suav nrog Rheumatoid mob caj dab (RA), psoriasis, mob ntshav qab zib nephropathy, atopic dermatitis, mob lupus erythematosus, thiab lwm yam. Muaj 4 hom JAK enzymes, uas yog JAK1 , JAK2, JAK3 thiab TYK2. JAK-nyob ntawm cytokines tau koom nrog hauv cov kab mob tshwm sim ntawm ntau yam kev mob qog noj ntshav thiab kab mob autoimmune, qhia tias JAK inhibitors tuaj yeem siv dav hauv kev kho mob ntau yam kab mob. Hauv kev kuaj pom kinase,baricitinibpom 100 zaug muaj zog tiv thaiv JAK1 thiab JAK2 dua JAK3.

Eli Lilly thiab Incyte tau txais kev pom zoo tshwj xeeb hauv xyoo 2009 los koom ua ke tsim Olumiant thiab qee qhov sib txuas tom ntej. Txog tam sim no, Olumiant tau pom zoo los ntawm ntau dua 70 lub tebchaws (suav nrog Tebchaws Meskas, European Union thiab Nyij Pooj) rau kev kho cov neeg laus uas muaj mob rheumatoid mob caj dab (RA). Thaum lub Kaum Ib Hlis 2020, Olumiant tau txais kev pom zoo los ntawm EU rau qhov kev qhia tshiab rau siv rau cov neeg laus uas muaj mob hnyav rau qhov mob hnyav ntawm daim tawv nqaij uas tsim nyog rau kev kho mob.

COV-BARRIER yog qhov kev xaiv, ob-qhov muag tsis pom, cov tshuaj placebo uas tau tshuaj xyuas qhov ua tau zoo ntawm qhov ncauj JAK inhibitor Olumiant (ib hnub ib zaug, 4 mg) ua ke nrog cov qauv kev saib xyuas (SoC) hauv kev kho mob hauv tsev kho mob COVID-19 cov neeg mob. SoC tuaj yeem suav nrog corticosteroids, tshuaj tiv thaiv kab mob, tshuaj tiv thaiv kab mob, thiab/lossis azithromycin. Txoj kev tshawb no tau pib thaum Lub Rau Hli 2020 thiab tso npe rau 1,525 tus neeg mob pw hauv tsev kho mob uas tsis xav tau cov pa ntxiv (tus cwj pwm tus cwj pwm [OS] yog 4), xav tau cov pa ntxiv (OS 5) lossis cov pa oxygen txaus/tsis ua pa tawm (OS 6). Cov neeg mob no tseem yuav tsum muaj qhov nce ntxiv tsawg kawg ib qho cim mob, uas yog qhov taw qhia ntawm kev pheej hmoo ntawm kev kis mob. Raws li kev xyaum kho mob hauv ib cheeb tsam, txhua tus neeg mob tau txais kev kho SoC, uas 79% tau txais corticosteroids (91% tau txais dexamethasone), 19% tau txaisRemdesivirntawm lub hauv paus, thiab qee tus neeg mob tau txais ob qho kev kho mob tib lub sijhawm. Hauv txoj kev tshawb fawb, cov neeg mob tau xaiv kom tau txais 4 mg qhov ncauj ntawm Olumiant lossis cov placebo ib hnub ib zaug ntawm qhov sib piv ntawm 1: 1 rau 14 hnub lossis txog thaum tso tawm.

Cov txiaj ntsig tau pom tias txoj kev tshawb fawb tsis mus txog qhov tseem ceeb ntawm kev suav sau thawj qhov kawg. Thawj qhov kawg tau piav qhia raws li: hnub 28, qhov feem pua ​​ntawm cov neeg mob uas tau nce mus rau qhov tau txais qhov tso pa tawm thawj zaug (suav nrog cov pa ntws loj) lossis cov tshuab ua pa nkag mus (suav nrog cov pa oxygen sab hauv (ECMO)) lossis tuag. Piv nrog cov placebo + SoC pab pawg kho mob (30.5%), Olumiant + SoC pab pawg kho mob (27.8%) muaj 2.7%tsis tshua muaj kev nce qib mus rau qhov nqus pa (tsis cuam tshuam lossis siv tshuab) lossis tuag . Qhov sib txawv no tsis muaj nuj nqis tseem ceeb (piv piv [OR]=0.85; 95%CI: 0.67-1.08; p=0.180).

Txawm li cas los xij, cov ntsiab lus tseem ceeb ua ntej thib ob pom tias hnub 28, Olumiant + SoC txo qhov kev pheej hmoo ntawm kev tuag los ntawm 39% piv nrog cov placebo + SoC (nominal p=0.0018; Olumiant group: 62 /764 [8.1%], pawg placebo: 101/761 [13.3%]; qhov phom sij piv txwv [HR]=0.56; 95%CI: 0.41, 0.77). Cov lej txo qis hauv kev tuag tau pom nyob hauv txhua pawg neeg mob hnyav ntawm cov neeg mob kho nrog Olumiant, thiab nws yog qhov tseem ceeb tshaj plaws hauv cov neeg mob uas tau txais lub tshuab ua pa tsis zoo ntawm lub hauv paus (cov neeg tuag hauv Olumiant + SoC pab pawg yog 17.5%, thiab cov placebo + Cov neeg tuag hauv pab pawg SoC yog 29.4%; kev phom sij [HR]=0.52; 95% CI: 0.33, 0.80; nominal p value=0.0065). Kuj tseem muaj kev txo qis kev tuag ntawm cov pab pawg ua ntej tau teev tseg ntawm cov neeg mob uas muaj lossis tsis muaj kev kho corticosteroid ntawm lub hauv paus.

Hauv txoj kev tshawb fawb, qhov xwm txheej ntawm cov xwm txheej tsis zoo thiab cov xwm txheej tsis zoo yog zoo ib yam hauv Olumiant pawg (44.5% thiab 14.7%, feem) thiab cov placebo pawg (44.4% thiab 18.0%, feem). Qhov tshwm sim ntawm kev kis mob hnyav thiab mob ntshav thromboembolism (VTE) yog 8.5% thiab 2.7% hauv pab pawg Olumiant, thiab 9.8% thiab 2.5% hauv pawg placebo, feem. Tsis muaj cov cim qhia kev nyab xeeb tshiab uas yuav cuam tshuam nrog kev siv Olumiant tau tshawb pom.

Xibfwb E. Wesley Ely, tus kws tshawb fawb tshawb fawb txog COV-BARRIER txoj kev tshawb fawb thiab tus thawj coj ntawm Kev Ua Haujlwm Tsis Txaus Siab Lub Hlwb Ua Haujlwm Tsis Zoo thiab Ciaj sia taus (CIBS) Center ntawm Vanderbilt University Medical Center, hais tias:" Cov ntaub ntawv kho mob tsis ntev los no pab peb nkag siab zoo Lub luag haujlwm ntawmbaricitinibhauv kev kho qee yam ntawm COVID-19 cov neeg mob pw hauv tsev kho mob, thiab kev nthuav dav ntawm EUA sawv cev rau cov kauj ruam tseem ceeb hauv kev tawm tsam tus kabmob sib kis no thiab yuav cawm txoj sia ntawm tsev kho mob COVID-19 cov neeg mob."