Eli Lilly Olumiant's (baricitinib) Qhov Kev Qhia Tawm Tshiab tau pom zoo los ntawm European Union!

Eli Lilly thiab nws tus khub Incyte tsis ntev los no tau tshaj tawm tias Cov European Commission (EC) tau pom zoo rau cov kev taw qhia tshiab rau qhov ncauj JAK inhibitor Olumiant (baricitinib): rau kev kho mob me ntsis mus rau hnyav atopic dermatitis uas tsim nyog rau kev kho kab mob (AD) Cov neeg laus.

Olumiant' s cov tshuaj ua cov tshuaj muaj txiaj ntsig yog baricitinib, uas yog qhov ncauj JAK1 / JAK2 inhibitor nrhiav tau los ntawm Incyte thiab tsim los ntawm Eli Lilly los ntawm Incyte' s daim ntawv tso cai.

Nws yog tshwj xeeb muaj nuj nqi hais tias Olumiant yog thawj JAK inhibitor kom tau txais kev pom zoo los tswj kev kho mob ntawm AD, nrog rau thawj qhov ncauj tshuaj rau kev kho AD.

Qhov kev qhia pom zoo tshiab yog los ntawm cov ntaub ntawv ntawm Olumiant' s Theem 3 BREEZE-AD kev txhim kho hauv chaw kho mob rau kev kho AD, suav nrog: (1) Ob txoj kev tshawb fawb ib leeg tshuaj ntawm Olumiant rau kev kho mob me ntsis mus rau mob hnyav AD cov neeg mob, BREEZE-AD1 thiab BREEZE-AD2; (2) Kev kawm ua ke ntawm Olumiant thiab tshuaj pleev corticosteroids hauv cov neeg mob uas muaj ntsis mus rau mob hnyav AD uas tsis muaj txiaj ntsig, tsis kam lees lossis tsis pom zoo rau cyclosporine BREEZE-AD4; (3) Kev kawm ua ke ntawm Olumiant ua ke nrog tshuaj pleev corticosteroids hauv kev kho mob me ntsis mus rau mob hnyav AD cov neeg mob BREEZE-AD7.

Txhua qhov kev tshawb fawb tau pom txog qhov kawg: thaum siv los ua kev kho mob thiab ua ke nrog cov txheej txheem ntawm kev saib xyuas cov corticosteroids, Olumiant txhim kho qhov mob hnyav tau sib piv nrog cov placebo, thiab qhov feem ntau ntawm cov neeg mob tau ua tiav kev tshem tawm ntawm cov tawv nqaij mob.

Atopic dermatitis (AD) yog ib hom mob ua mob rau daim tawv nqaij, ua rau pom khaus heev, ua rau pom kev hloov tawv nqaij zoo li daim tawv thiab qhuav tawv. Tus mob feem ntau pib rau cov menyuam mos thiab menyuam yaus, thiab qee tus neeg mob tas lawv lub neej. Nws tuaj yeem ua rau lub neej tsis zoo ntawm cov neeg mob vim qhov kev mob tshwm sim zoo li ua pob liab vog, khaus khaus, tsis muaj pw tsaug zog, kev txwv kev noj zaub mov, thiab muaj kev puas siab puas ntsws.

Olumiant cov tshuaj nquag muaj nqis yog baricitinib, uas yog ib qho kev xaiv thiab thim rov qab los ntawm JAK1 thiab JAK2 inhibitor uas noj ntawm qhov ncauj ib zaug ib hnub thiab tam sim no nyob rau hauv kev kho mob txhim kho rau kev kho mob ntawm ntau yam mob thiab mob tiv thaiv kab mob, nrog rau Rheumatoid kev mob caj dab (RA), psoriasis, ntshav qab zib nephropathy, atopic dermatitis, kab ke lupus erythematosus, thiab lwm yam Muaj 4 hom JAK enzymes, uas yog JAK1, JAK2, JAK3 thiab TYK2. JAK-cytokines muaj kev cuam tshuam rau hauv lub pathogenesis ntawm ntau yam inflammations thiab autoimmune kab mob, hais tias JAK inhibitors yuav siv dav hauv kev kho ntau yam kab mob. Hauv kev ntsuas kev soj ntsuam kinase, baricitinib pom 100 zaug muaj zog dua kev tiv thaiv tawm tsam JAK1 thiab JAK2 dua li JAK3.

Eli Lilly thiab Incyte tau mus txog rau kev cog lus kev koom tes tshwj xeeb hauv xyoo 2009 los tsim kho Olumiant thiab qee lub tebchaw txuas ntxiv. Txog tam sim no, Olumiant tau txais kev pom zoo los ntawm ntau dua 60 lub teb chaws (suav nrog Tebchaws Meskas, European Union thiab Nyij Pooj) ua ib qho yeeb tshuaj lossis sib xyaw nrog methotrexate rau kev kho mob rau ib lossis ntau hom kabmob los kho tus mob rheumatic (DMARD) Kev Kho Mob ntawm cov neeg mob tsis txaus lossis tsis kam lees cov neeg laus cov neeg laus uas mob hnyav mus txog mob rheumatoid mob caj dab (RA). Hauv cov kev tshawb fawb soj ntsuam, piv nrog cov qauv kev kho mob (xws li methotrexate monotherapy, adalimumab ua ke nrog kev kho mob tom qab methotrexate), Oluminant pom tau zoo dua cov tsos mob thiab cov cim ntawm RA.

Txog kev kho mob RA, Olumiant' s pom zoo koob tshuaj hauv EU yog 4mg thiab 2mg, thiab cov tshuaj pom zoo hauv Tebchaws Meskas yog 2mg. Hais txog kev noj tshuaj, Olumiant noj qhov ncauj ib hnub ib zaug, raws li ib tus neeg sawv cev lossis ua ke nrog methotrexate (MTX) lossis lwm yam kab mob uas tsis yog tshuaj lom neeg hloov kho los tiv thaiv kev kho mob (tsis yog-biologic DMARDs). Nws tsis pom zoo kom muab Olumiant nrog lwm cov tshuaj JAK inhibitors, lossis DMARDs biological, thiab cov tshuaj tiv thaiv kab mob muaj zog (xws li azathioprine thiab cyclosporine). Nws yog tsim nyog sau cia tias Olumiant Tebchaws Asmeskas cov ntawv qhia tshuaj muaj nrog cov lus ceeb toom hauv lub thawv dub, qhia txog qhov kev pheej hmoo ntawm kev kis tus mob hnyav, kev ua tsis zoo thiab mob ntsws.