Gilead/Galapagos Oral Jyseleca Yuav Tau Pom Zoo sai sai hauv EU: Txhim kho cov tsos mob thiab kev pab ntev!

Galapagos NV, tus khub ntawm Gilead Sciences, tsis ntev los no tau tshaj tawm tias European Medicines Agency (EMA) Pawg Neeg Saib Xyuas Kev Siv Tshuaj Kho Mob rau Tib Neeg (CHMP) tau tshaj tawm cov kev tshuaj xyuas zoo uas pom zoo pom zoo ntawm qhov ncauj tshuaj tiv thaiv kab mob Jyseleca (filgotinib ib). Nws yog qhov ncauj qhov ncauj JAK1 qhov tseem ceeb inhibitor ib hnub ib zaug 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.

Tam sim no, CHMP cov kev xav yuav raug xa mus rau European Commission (EC) rau kev tshuaj xyuas, uas feem ntau ua rau kev txiav txim siab zaum kawg hauv 2 lub hlis. Yog tias pom zoo, 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 US FDA tsis tau pom zoo ib qho qhia rau Jyseleca vim qhov kev xav txog kev nyab xeeb.

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 rau kev kho mob ntawm cov neeg mob nruab nrab mus rau cov neeg mob hnyav uas tsis txaus lossis intolerance rau ib lossis ntau tus kab mob-hloov tshuaj tiv thaiv kab mob (DMARD) Cov neeg laus uas muaj mob rheumatoid mob caj dab (RA). Hais txog cov tshuaj, Jyseleca tuaj yeem siv los ua monotherapy lossis ua ke nrog methotrexate (MTX). Tam sim no, Jyseleca' daim ntawv thov kev kho mob ntawm UC cov lus qhia tseem tab tom raug tshuaj xyuas hauv tebchaws United Kingdom thiab Nyij Pooj.

Nws yog ib qho tsim nyog hais tias nyuam qhuav dhau los, AbbVie tau xa daim ntawv qhia tshiab rau qhov ncauj JAK1 inhibitor Rinvoq (upadacitinib) rau US FDA thiab EU EMA: rau kev kho mob ntawm cov neeg mob nruab nrab mus rau UC cov neeg laus. Rinvoq kuj yog ib qho kev xaiv ntawm qhov ncauj JAK1 inhibitor.

CHMP cov kev xav zoo yog nyob ntawm 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 txais biologics) cov neeg mob, thiab tom qab ntawd kev kawm txog 47-lub lim tiam 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 ib, uas yog ib qho kev xaiv JAK1 inhibitor nrhiav thiab tsim los ntawm Galapagos. Thaum kawg ntawm lub Kaum Ob Hlis 2015, Gilead tau pom zoo nrog Galapagos tag nrho 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 cog lus kev loj hlob ntawm filgotinib thaum 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 tiav thaum kawg ntawm 2021. ), hos Kile-a yuav ua lub luag haujlwm ntxiv musfilgotinib ibsab nraum Tebchaws Europe, suav nrog Nyiv (qhov twg Gilead yuav koom ua ke muag filgotinib nrog Eisai).

Tam sim no,filgotinib ibtab 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 cov khoom lag luam, 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 cov qhia tshiab ntawm ib tug xov tooj ntawm JAK inhibitors, suav nrog Pfizer.abrocitinibrau 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 AD, Rinvoq kho mob nruab nrab mus rau AD thiab nquag PsA.

Yog vim li cas yog tias, hauv kev tshawb fawb txog 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 thov cov tuam txhab tshuaj muaj feem cuam tshuam los muab cov ntaub ntawv txheeb xyuas ntxiv.