EU pom zoo qhov qhia tshiab rau qhov ncauj JAK1 inhibitor Jyseleca (filgotinib)!

Galapagos NV, tus khub ntawm Gilead Sciences, tsis ntev los no tshaj tawm tias European Commission (EC) tau pom zoo ib qho kev qhia tshiab rau qhov ncauj tshuaj tiv thaiv kab mob Jyseleca (filgotinib, 200mg ntsiav tshuaj), uas yog ib zaug ib hnub ntawm qhov ncauj JAK1 Ib qho tseem ceeb inhibitor rau kev kho mob ntawm nruab nrab mus rau hnyav ulcerative colitis (UC) cov neeg laus uas tsis txaus cov lus teb, tsis ua hauj lwm los yog intolerance rau cov pa kev kho mob los yog cov kab mob lom. Nrog rau kev pom zoo ntawm cov lus qhia tshiab, Jyseleca yuav muab kev kho mob tshiab rau cov neeg mob uas muaj mob nruab nrab mus rau hnyav UC hauv European Union. Nws yog ib qho tsim nyog sau cia tias, vim muaj kev xav txog kev nyab xeeb, US FDA tsis tau pom zoo ib qho qhia rau Jyseleca.

Jyseleca yog ib qho kev xaiv ntawm qhov ncauj JAK1 inhibitor uas tau pom zoo rau kev lag luam hauv European Union, United Kingdom, thiab Nyij Pooj (Jyseleca 100mg thiab 200mg ntsiav tshuaj) rau kev kho mob ntawm cov lus teb tsis txaus rau ib lossis ntau tus kab mob-hloov tshuaj tiv thaiv kab mob (DMARD ) lossis cov neeg laus cov neeg mob uas muaj mob hnyav rau mob rheumatoid mob caj dab (RA) intolerance. Hais txog kev siv tshuaj, Jyseleca tuaj yeem siv los ua monotherapy lossis ua ke nrog methotrexate (MTX). Tam sim no, Jyseleca' daim ntawv thov rau kev kho mob ntawm UC cov lus qhia tseem tab tom saib xyuas kev tswj hwm hauv tebchaws United Kingdom thiab Nyij Pooj.

Nws yog tsim nyog hais tias nyob rau lub Cuaj Hli Ntuj xyoo no, AbbVie tau xa ib daim ntawv thov qhia tshiab rau qhov ncauj JAK1 inhibitor Rinvoq (upadacitinib, upatinib) rau US FDA thiab EU EMA: rau kev kho mob ntawm nruab nrab mus rau hnyav UC cov neeg laus. Rinvoq kuj yog ib qho kev xaiv ntawm qhov ncauj JAK1 inhibitor.

Kev pom zoo ntawm qhov qhia tshiab no yog ua raws cov ntaub ntawv los ntawm qhov tseem ceeb 2b/3 SELECTION project. Qhov project no tau soj ntsuam qhov ua tau zoo thiab kev nyab xeeb ntawm Jyseleca raws li kev kho mob thiab kev kho mob hauv nruab nrab rau cov neeg laus UC cov neeg laus uas ua tsis tau raws li kev kho mob lossis kev kho mob biologics. SELECTION suav nrog 2 cov kev tshawb fawb txog cov placebo-tswj induction, ib qho rau cov neeg mob uas tau biologic-naive (biologic-naive, tsis tau txais biologics yav tas los), thiab lwm yam rau biologic-experienced (biologic-experienced, yav tas los tau biologics) Cov neeg mob, thiab tom qab ntawd ib 47-lub lim tiam kev saib xyuas rau cov neeg mob uas teb rau Jyseleca tom qab 10 lub lis piam ntawm kev kho mob. Cov neeg teb cov placebo txuas ntxiv siv cov placebo dig muag thaum lub sijhawm tu. Cov txiaj ntsig ntawm SELECTION mus sib hais tsis ntev los no tau tshaj tawm hauv The Lancet, saib: Filgotinib ua induction thiab kev kho mob rau ulcerative colitis (SELECTION): ib theem 2b/3 ob-dig muag, randomised, placebo-tswj sim.

filgotinib molecular qauv

Ulcerative colitis (UC) yog ib hom kab mob plab hnyuv loj (IBD). Cov tsos mob ntawm tus kab mob no feem ntau tsis sib xws, yog li cov neeg mob feem ntau ntsib kev tawm tsam thiab tshem tawm. Ntxiv nrog rau qhov cuam tshuam rau lub cev, tus kab mob kuj tuaj yeem ua rau muaj kev puas siab puas ntsws loj.

Cov khoom xyaw tshuaj nquag ntawm Jyseleca yogfilgotinib, uas yog ib qho kev xaiv JAK1 inhibitor, nrhiav tau thiab tsim los ntawm Galapagos. Thaum kawg ntawm lub Kaum Ob Hlis 2015, Gilead tau pom zoo nrog Galapagos rau tag nrho cov nyiaj txog li 2 billion US dollars los koom ua ke tsim thiab ua lag luam filgotinib thoob ntiaj teb. Txawm li cas los xij, vim muaj teeb meem loj hauv Teb Chaws Asmeskas txoj cai, ob tog tau hloov kho kev lag luam thiab kev pom zoo ntawm kev txhim khofilgotinibThaum Lub Kaum Ob Hlis 2020. Galapagos yuav yog lub luag haujlwm rau kev lag luam ntawm filgotinib hauv Tebchaws Europe (lub sijhawm hloov pauv yuav tsum ua kom tiav thaum kawg ntawm 2021), thaum Gilead tseem yuav ua lub luag haujlwm rau filgotinib sab nraud Europe, suav nrog Nyiv (qhov twg Gilead yuav koom ua ke. muag filgotinib nrog Eisai).

Tam sim no,filgotinibtab tom tsim los kho ntau yam kab mob inflammatory, ntawm theem 3 kev tshawb fawb suav nrog kev kho mob rheumatoid mob caj dab, Crohn's kab mob, thiab mob plab ulcerative. Txawm li cas los xij, hauv thaj tsam ntawm JAK inhibitors, filgotinib tseem ntsib ntau yam khoom sib tw. Ntxiv rau ob qho khoom lag luam uas tau teev tseg Pfizer Xeljanz thiab Eli Lilly Olumiant, tus neeg sib tw muaj zog yuav yog AbbVie' s Rinvoq (upadacitinib).

Nws yog ib nqi sau cia hais tias nyob rau hauv thawj ib nrab ntawm lub xyoo no, US FDA tau ncua lub sij hawm ntsuam xyuas rau tshiab indications ntawm ntau JAK inhibitors, xws li Pfizer abrocitinib (abxitinib) rau kev kho mob ntawm nruab nrab mus rau mob atopic dermatitis (AD), Xeljanz / Xeljanz. XR kho ankylosing spondylitis (AS), Olumiant kho mob nruab nrab mus rau hnyav AD, Rinvoq kho mob nruab nrab mus rau AD thiab nquag PsA.

Yog vim li cas yog tias, hauv kev tshawb nrhiav kev nyab xeeb tom qab kev lag luam luam tawm thaum Lub Ib Hlis xyoo no, nws tau pom tias Xeljanz yuav ua rau muaj kev pheej hmoo ntawm cov kab mob plawv loj thiab mob qog noj ntshav piv nrog cov tshuaj TNF inhibitors. Tam sim no, US FDA tau tshuaj xyuas txhua yam tshuaj hauv JAK inhibitor qeb. Lub chaw haujlwm tau hais kom cov tuam txhab tshuaj muaj feem cuam tshuam los muab cov ntaub ntawv txheeb xyuas ntxiv.