Olumiant (baricitinib) daim ntawv thov qhia tshiab tau ncua hauv Asmeskas tshuaj xyuas!

Eli Lilly thiab nws tus khub Incyte tsis ntev los no tshaj tawm tias Asmeskas Khoom Noj thiab Tshuaj Yeeb Tshuaj (FDA) yuav tsis ntxiv cov tshuaj tshiab rau qhov ncauj JAK inhibitor Olumiant (baricitinib) ntawm lub hom phiaj ua hnub ntawm Txoj Cai Siv Tshuaj Yeeb Tshuaj (PDUFA) Daim Ntawv Thov (sNDA) los tshuaj xyuas qhov kev txiav txim siab. Lub sNDA nrhiav kev pom zoo qhov kev qhia tshiab rau Olumiant: rau kev kho mob ntawm cov neeg laus nrog mob hnyav rau mob hnyav atopic dermatitis (AD). Eli Lilly tau hais tias FDA' kev nqis tes ua yuav tsis cuam tshuam rau lub tuam txhab' yav dhau los 2021 kev qhia txog nyiaj txiag.

Qhov kev ncua no cuam tshuam nrog kev tshuaj xyuas txuas ntxiv ntawm JAK inhibitors los ntawm FDA. JAK inhibitors yog chav kawm ntawm kev cog lus kho tshiab uas tuaj yeem siv los kho ntau yam kab mob autoimmune, tab sis cov tshuaj no tau raug nug vim muaj teeb meem kev nyab xeeb.

Olumiant' cov tshuaj muaj tshuaj muaj yees yogbaricitinib, qhov ncauj JAK1/JAK2 inhibitor pom los ntawm Incyte thiab tsim los ntawm Eli Lilly raws li daim ntawv tso cai ntawm Incyte. Thaum lub Kaum Ib Hlis 2020, Olumiant tau pom zoo los ntawm European Union rau kev kho mob nruab nrab txog rau cov neeg laus laus AD uas tsim nyog rau kev kho mob. Nws tsim nyog hais tias Olumiant yog lub ntiaj teb' thawj JAK inhibitor pom zoo rau kev kho mob ntawm atopic dermatitis (AD). Hauv Tebchaws Meskas, thaum pib lub Plaub Hlis xyoo no, FDA tau ncua sijhawm tshuaj xyuas Olumiant rau AD cov cim qhia los ntawm 3 lub hlis mus txog rau lub hlis thib peb ntawm xyoo 2021.

Ilya Yuffa, tus lwm thawj coj laus thiab tus thawj tswj hwm ntawm Eli Lilly Biopharmaceuticals, hais tias:" Peb muaj kev ntseeg siab rau qhov ua tau zoo thiab nyab xeeb ntawm Olumiant hauv kev kho mob atopic dermatitis, thiab tos ntsoov yuav koom tes nrog FDA thaum lub sijhawm seem txheej txheem tshuaj xyuas. Peb tau cog lus tias yuav coj Olumiant ua ke. Ua lag luam los pab ua kom tau raws li qhov xav tau ntawm cov neeg mob atopic dermatitis."

Atopic dermatitis (AD) yog mob hnyav ntawm daim tawv nqaij ua rau tawv nqaij, feem ntau tshwm sim los ntawm kev khaus khaus, pom kev zoo ib yam li hloov pauv thiab tawv nqaij qhuav. Tus kab mob no feem ntau pib hauv menyuam mos thiab menyuam yaus, thiab qee tus neeg mob ua rau lawv tag sim neej. Nws tuaj yeem cuam tshuam loj rau lub neej zoo ntawm cov neeg mob vim muaj mob rov zoo li mob pob khaus, khaus khaus, tsis tsaug zog, txwv kev noj zaub mov, thiab cuam tshuam rau lub hlwb.

Olumiant cov khoom siv tshuaj muaj yees yogbaricitinib, uas yog xaiv thiab thim rov qab JAK1 thiab JAK2 inhibitor. 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 mob rheumatoid mob caj dab (RA), psoriasis, mob ntshav qab zib nephropathy, atopic dermatitis (AD), mob lupus erythematosus (SLE), cov menyuam yaus idiopathic mob caj dab (JIA), 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 kinase kuaj pom, baricitinib pom 100 zaug muaj zog tiv thaiv JAK1 thiab JAK2 dua JAK3.

Txog tam sim no, Olumiant tau pom zoo thiab ua lag luam hauv ntau dua 75 lub tebchaws (suav nrog Tebchaws Meskas, Tuam Tshoj, European Union, thiab Nyij Pooj) rau kev kho cov neeg laus uas muaj mob hnyav rau mob rheumatoid mob caj dab (RA). Ib qho ntxiv, Olumiant tau pom zoo rau kev kho mob ntawm cov neeg laus uas muaj mob hnyav rau mob khaub thuas hnyav (AD) hauv ntau dua 40 lub tebchaws (suav nrog tag nrho European Union thiab Nyij Pooj). Tsis ntev los no, Olumiant kuj tau pom zoo hauv Nyij Pooj rau kev kho mob ntawm COVID-19 ntsig txog mob ntsws hauv tsev kho mob cov neeg laus.

Rau kev kho RA, Olumiant' pom zoo koob tshuaj hauv EU yog 4mg thiab 2mg, koob tshuaj pom zoo hauv Tebchaws Meskas yog 2mg, thiab koob tshuaj pom zoo hauv Suav teb yog 2mg. Hais txog kev siv tshuaj, Olumiant tau hais lus ib zaug ib hnub, ua ib tus neeg sawv cev lossis ua ke nrog methotrexate (MTX) lossis lwm yam kab mob tsis yog tshuaj lom neeg hloov kho tshuaj tiv thaiv kab mob rheumatic (tsis yog biologic DMARDs). Nws tsis pom zoo muab Olumiant nrog lwm JAK inhibitors, lossis DMARDs lom, thiab muaj zog tiv thaiv kab mob (xws li azathioprine thiab cyclosporine). Nws tsim nyog sau cia tias Olumiant' Asmeskas daim ntawv lo tshuaj tau nrog daim ntawv ceeb toom lub thawv dub, qhia tias muaj kev pheej hmoo kis mob hnyav, mob qog noj ntshav thiab mob ntshav khov.