Rinvoq tab tom yuav raug pom zoo hauv EU rau nws qhov kev qhia plaub: kev kho cov neeg laus AD thiab cov hluas!

AbbVie tsis ntev los no tshaj tawm tias European Lub Chaw Haujlwm Tshuaj (EMA) Pawg Saib Xyuas Khoom Kho Mob rau Kev Siv Tib Neeg (CHMP) tau tshaj tawm cov lus pom zoo los tawm tswv yim pom zoo pom zoo los ntawm Rinvoq (upadacitinib) raws li qhov kev qhia tshiab rau kev kho mob uas tsim nyog kho cov neeg laus uas mob hnyav rau mob hnyav atopic dermatitis (AD) (15mg lossis 30mg, ib hnub ib hnub) thiab cov neeg mob hluas hnub nyoog 12 xyoos thiab laus dua (15mg, ib hnub ib zaug).

Tam sim no, CHMP cov kev xav yuav xa mus rau European Commission (EC) txhawm rau tshuaj xyuas, uas xav tias yuav txiav txim siab zaum kawg hauv ob lub hlis tom ntej no. Yog pom zoo, qhov no yuav yog Rinvoq' qhov kev qhia thib plaub hauv EU, thiab Rinvoq tseem yuav dhau los ua EU' thawj JAK inhibitor rau kev kho mob ntawm cov neeg laus laus thiab cov hluas (≥ 12 xyoos).

Rinvoq yog qhov ncauj, ib zaug ib hnub, xaiv thiab thim rov qab JAK inhibitor. Hauv European Union, yav dhau los Rinvoq tau pom zoo rau 3 qhov qhia: (1) Rau kev kho mob ntawm mob rheumatoid mob caj dab mus rau qhov tsis txaus lossis tsis mob siab rau ib lossis ntau yam kab mob-kho tshuaj tiv thaiv rheumatic (DMARD) (RA) cov neeg laus; (2) rau kev kho mob ntawm cov neeg laus uas muaj mob psoriatic mob caj dab (PsA) uas tsis txaus lossis tsis kam ua rau ib lossis ntau DMARDs; (2) rau kev kho mob ntawm cov lus teb tsis txaus rau cov kev kho mob pom zoo Cov neeg laus uas muaj mob ankylosing spondylitis (AS). Ntawm cov kev qhia no, qhov pom zoo koob tshuaj Rinvoq yog 15 mg.

Qhov kev tshuaj xyuas zoo ntawm CHMP yog ua raws cov ntaub ntawv txhawb nqa ntawm Phase 3 cov haujlwm thoob ntiaj teb. Txoj haujlwm suav nrog 3 qhov kev tshawb fawb tseem ceeb hauv ntiaj teb (Ntsuas Up 1, Ntsuas Up 2, AD Up), tso npe ntau dua 2500 tus neeg mob uas muaj mob hnyav rau mob khaub thuas hnyav (AD). Hauv peb qhov kev tshawb fawb, ob koob tshuaj ntawm Rinvoq tau mus txog txhua qhov kawg thiab theem kawg: piv nrog cov pab pawg placebo, cov neeg mob hauv Rinvoq pawg kho mob tau mob txhab nqaij tawv thiab tshem tawm ntawm lub lim tiam 16 thiab lwm lub sijhawm (p< 0.001)="" )="" piv="" nrog="" cov="" placebo="" pawg.="" muaj="" kev="" txhim="" kho="" sai="" thiab="" tseem="" ceeb="" ntawm="" qhov="" khaus.="" hauv="" txoj="" kev="" tshawb="" fawb,="" qhov="" tshwm="" sim="" tsis="" zoo="" feem="" ntau="" hauv="" cov="" neeg="" mob="" kho="" nrog="" rinvoq="" yog="" pob="" txuv,="" nasopharyngitis,="" thiab="" mob="" ua="" pa="" kab="" mob="" ua="">

Hauv Tebchaws Meskas, Rinvoq tsuas yog pom zoo rau kev kho mob ntawm mob hnyav rau mob rheumatoid mob caj dab (RA) cov neeg laus uas tsis txaus lossis ua tsis tau siab rau methotrexate (MTX). Qhov koob tshuaj pom zoo rau qhov ntsuas no yog 15 mg. Tam sim no, Rinvoq' daim ntawv thov ntxiv rau kev kho mob PsA, AS, thiab AD tab tom raug tshuaj xyuas los ntawm Asmeskas FDA.

Tsis ntev los no, AbbVie tseem tau muab Asmeskas cov cai hloov tshiab ntawm Rinvoq' kev kho mob ntawm PsA thiab AS. FDA tau ceeb toom rau lub tuam txhab tias nws yuav tsis tuaj yeem txiav txim siab Rinvoq' daim ntawv thov ntxiv (sNDA) rau kev kho PsA thiab AS ua ntej hnub PDUFA lub hom phiaj. Tam sim no, lub chaw haujlwm tau tshuaj xyuas kev tshawb fawb tom qab kev lag luam los ntawm Pfizer, ORAL Surveillance, uas tab tom tshuaj xyuas kev nyab xeeb ntawm qhov ncauj JAK inhibitor Xeljanz (tofacitinib, tofacitinib) hauv kev kho RA. Tam sim no, FDA tseem tsis tau ua raws txoj cai lij choj ntawm Rinvoq' sNDA hauv kev kho PsA thiab AS. Ib qho ntxiv, Rinvoq' sNDA hauv kev kho AD tau ncua rau 3 lub hlis thaum lub Plaub Hlis xyoo no mus rau peb lub hlis twg ntawm 2021.

Atopic dermatitis (AD) yog ib qho tshwm sim, mob ntev, rov tshwm sim, thiab kab mob ntawm daim tawv nqaij, tshwm sim los ntawm kev rov ua dua ntawm khaus thiab khawb, ua rau tawg, tawv nqaij, thiab tawv nqaij exudative. Nws tau kwv yees tias ntau npaum li 25% ntawm cov menyuam thiab 10% ntawm cov neeg laus yuav raug cuam tshuam los ntawm AD ntawm qee kis hauv lawv lub neej. 20% -46% ntawm cov neeg laus AD cov neeg mob yuav muaj mob hnyav mus rau mob hnyav. Cov tsos mob ntawm tus kab mob yuav ua rau lub cev, lub paj hlwb thiab nyiaj txiag tseem ceeb rau tus neeg mob.

Cov khoom siv tshuaj muaj zog ntawm Rinvoq yogupadacitinib, uas yog qhov ncauj xaiv thiab thim rov qab JAK1 inhibitor pom thiab tsim los ntawm AbbVie. Nws tau tsim los kho ntau yam kab mob tiv thaiv kab mob. JAK1 yog kinase uas ua lub luag haujlwm tseem ceeb hauv cov kab mob pathology ntawm ntau yam kab mob sib kis.

Tam sim no, Rinvoq (upadacitinib) kho cov kab mob ulcerative (UC), mob caj dab rheumatoid (RA), psoriatic mob caj dab (PsA), axial spondyloarthritis (axSpA), Crohn's disease (CD), atopic Phase III kev tshawb fawb soj ntsuam ntawm kev sib daj sib deev (AD) thiab cov kab mob loj heev ntawm tes (GCA) tab tom ua.

Kev lag luam zoo heev txog Rinvoq' kev cia siab rau kev lag luam. UBS cov kws tshuaj ntsuam yav dhau los kwv yees tias Rinvoq thiab AbbVie' lwm yam monoclonal antibody anti-inflammatory tshuaj Skyrizi yuav muaj qhov muag siab tshaj ntawm 11 txhiab nyiaj daus las Asmeskas las. Ob yam khoom tshiab no yuav tuaj yeem ua rau poob ntawm kev muag khoom los ntawm kev cuam tshuam ntawm biosimilars ntawm AbbVie' cov khoom lag luam tseem ceeb Humira (Humira, adalimumab).

Humira yog lub ntiaj teb' thawj qhov pom zoo los tiv thaiv qog nqaij hlav necrosis factor alpha (TNF-α) tshuaj thiab ntiaj teb' muag tshuaj tiv thaiv kab mob zoo tshaj plaws. Nws kev muag khoom thoob ntiaj teb xyoo 2020 ze txog 20 txhiab nyiaj daus las Asmeskas (19.832 nphom Asmeskas las). Hauv European Union, tus lej adalimumab biosimilars tau nyob hauv khw. Hauv Asmeskas kev ua lag luam, Humira yuav raug ntaus los ntawm biosimilars xyoo 2023.