AbbVie inhibitor Rinvoq (upatinib) xa daim ntawv thov qhia tshiab hauv Asmeskas thiab EU!

AbbVie tsis ntev los no tshaj tawm tias nws tau xa daim ntawv thov kev cai rau Rinvoq (upadacitinib) mus rau US Food and Drug Administration (FDA) thiab European Medicines Agency (EMA): 45mg induction koob, 15mg thiab 30mg noj koob tshuaj rau kev kho mob ntawm cov neeg laus uas muaj nruab nrab mus rau hnyav ulcerative colitis (UC). Rinvoq yog qhov ncauj, ib zaug ib hnub, xaiv thiab thim rov qab JAK inhibitor tsim los kho ntau yam kab mob tiv thaiv kab mob sib kis.

Nyob rau hauv European Union, Rinvoq 15mg tau pom zoo rau 4 qhov taw qhia: (1) rau kev kho mob ntawm cov neeg laus cov neeg mob uas muaj mob rheumatoid mob caj dab (RA); (2) rau kev kho mob psoriatic mob caj dab (PsA) cov neeg laus; (3) rau kev kho mob ntawm cov neeg laus cov neeg mob uas muaj active ankylosing spondylitis (AS); (4) rau kev kho mob ntawm cov neeg laus uas muaj mob nruab nrab mus rau mob atopic dermatitis (AD) thiab cov tub ntxhais hluas cov neeg mob hnub nyoog 12 xyoos thiab laus dua. Hauv European Union, Rinvoq 30mg tau pom zoo rau 1 qhov taw qhia: nws yog siv los kho cov neeg laus uas muaj hnub nyoog qis dua rau AD hnub nyoog qis dua 65 xyoos.

Hauv Tebchaws Meskas, Rinvoq 15mg tsuas yog pom zoo rau 1 qhov taw qhia: nws yog siv los kho cov neeg laus uas muaj mob rheumatoid mob caj dab (RA). Tam sim no, Rinvoq' daim ntawv thov ntxiv rau kev kho mob ntawm PsA, AS, thiab AD tab tom tshuaj xyuas los ntawm US FDA.

Daim ntawv thov no tau txais kev txhawb nqa los ntawm cov ntaub ntawv los ntawm 2 theem 3 induction kev tshawb fawb (U-ACHIEVE, U-ACCOMPLISH) thiab 1 theem 3 kev kawm tu (U-ACHIEVE Maintenance). Hauv kev tshawb fawb induction (Rinvoq 45mg) kev kho mob lub lim tiam 8 thiab kev saib xyuas kev kho mob (Rinvoq 15mg thiab 30mg) lub lim tiam 52, piv nrog cov placebo pab pawg, qhov feem pua ​​​​ntawm cov neeg mob hauv pab pawg kho mob Rinvoq uas tau mus txog qhov kawg ntawm qhov kawg (kev kho mob) thiab tag nrho cov ntsiab lus thib ob tseem ceeb dua.

Hauv cov kev tshawb fawb no, cov txiaj ntsig kev nyab xeeb ntawm Rinvoq, suav nrog 45mg koob tshuaj raws li kev kho mob induction, feem ntau ua raws li cov yam ntxwv kev nyab xeeb paub ntawm Rinvoq, thiab tsis muaj qhov tseem ceeb ntawm kev nyab xeeb tshiab tau pom.

Tom Hudson, AbbVie's Chief Scientific Officer thiab Senior Vice President of Research and Development, tau hais tias: “Muaj ntau tus neeg mob tseem muaj teeb meem nrog cov kab mob ulcerative colitis (UC) cov tsos mob, xws li qaug zog, mob plab, mob plab, thiab mob plab.upadacitinibmuaj peev xwm Nws yog ib qho tseem ceeb ntawm kev kho mob tshiab rau UC cov neeg mob uas vam tias yuav daws tau cov tsos mob nyuaj thiab puas tsuaj. Peb tos ntsoov yuav ua haujlwm nrog cov koom haum tswj hwm thiab vam tias yuav siv upadacitinib rau kev kho mob ntawm UC cov neeg mob sai li sai tau."

Rinvoq cov ntaub ntawv kho mob

Ulcerative colitis (UC) yog ib qho mob ntev, idiopathic, tiv thaiv kab mob hauv plab hnyuv (IBD) ntawm txoj hnyuv loj, uas tuaj yeem ua rau mob mucosal mob, txuas mus rau lub qhov quav mus rau qhov ze tshaj plaws ntawm txoj hnyuv mus rau qhov sib txawv. Cov cim qhia thiab cov tsos mob ntawm UC muaj xws li los ntshav ntawm qhov quav, mob plab, ntshav raws plab, tenesmus, ceev, thiab fecal incontinence. Chav kawm ntawm UC txawv ntawm tus neeg mob mus rau tus neeg mob. Nws tuaj yeem yog kab mob zoo li qub lossis mob ntev, kab mob refractory. Qee zaum, nws yuav ua rau muaj kev phais lossis muaj teeb meem, nrog rau mob qog noj ntshav lossis tuag. Qhov hnyav ntawm cov tsos mob thiab qhov tsis paub tseeb ntawm tus txheej txheem tus kab mob tuaj yeem ua rau lub nra hnyav rau UC cov neeg mob, thiab lawv feem ntau yog neeg xiam oob qhab.

Cov tshuaj nquag muaj ntawm Rinvoq yogupadacitinib, uas yog qhov ncauj xaiv thiab thim rov qab JAK1 inhibitor nrhiav thiab tsim los ntawm AbbVie. Nws raug tsim los kho ntau yam kab mob tiv thaiv kab mob sib kis. JAK1 yog kinase uas ua lub luag haujlwm tseem ceeb hauv pathophysiology ntawm ntau yam kab mob inflammatory. Tam sim no, Rinvoq kho ulcerative colitis (UC), rheumatoid mob caj dab (RA), psoriatic mob caj dab (PsA), atopic dermatitis (AD), axial spondyloarthritis (axSpA), Crohn Theem 3 kev tshawb fawb ntawm En' (CD) thiab giant cell arteritis (GCA) tab tom ua.

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

Humira yog lub ntiaj teb' thawj zaug pom zoo los tiv thaiv qog necrosis yam alpha (TNF-α) tshuaj thiab lub ntiaj teb' cov tshuaj zoo tshaj plaws muag tshuaj tiv thaiv. Nws cov kev muag khoom thoob ntiaj teb hauv 2020 yog ze rau 20 billion US dollars (19.832 billion US dollars). Hauv European Union, ntau tus adalimumab biosimilars tau nyob hauv khw. Hauv Asmeskas kev lag luam, Humira yuav raug ntaus los ntawm biosimilars hauv 2023.