Thawj Qhov Kev Xaiv Tso Hauv Chaw Ncauj C5a Tus Txais Txais Av Avacopan Nkag Qhov Kev Ntsuam Xyuas Hauv EU!

Vifor Fresenius Medical lub raum Tshuaj Lub Tuam Txhab (VFMCRP), lub chaw muag khoom ntawm Vifor Pharmaceuticals, thiab ChemoCentryx tsis ntev los no tshaj tawm tias Lub Chaw Haujlwm European Tshuaj (EMA) tau lees txais daim ntawv thov kev lag luam (MAA) rau avacopan (CCX168), uas yog siv los kho tshuaj antineutrophils Anti. -neutrophil cytoplasmic antibodies (ANCA) -related vasculitis (granulomatosis nrog polyangiitis [GPA] thiab microscopic polyangiitis [MPA]), uas yog ib qho mob tsis tshua muaj thiab mob autoimmune, Muaj cov neeg mob tsis txaus ntseeg kom tau txais kev kho mob tshwj xeeb.

Yog tias pom zoo, avacopan yuav dhau los ua thawj qhov ncauj, xaiv ntxiv 5a receptor (C5aR) inhibitor rau kev kho mob ntawm ANCA-cuam tshuam rau vasculitis. Cov ntaub ntawv los ntawm lub ntiaj teb tseem ceeb theem 3 ADVOCATE kev soj ntsuam kev sim pom tau hais tias piv nrog cov pab pawg kho mob prednisone, avacopan kho pab pawg muaj cov txiaj ntsig zoo nyob hauv kev kho mob nyob rau lub limtiam 52. Hauv qhov kev sim no, piv nrog prednisone kho pawg, glucocorticoid toxicity ntawm avacopan kho pab pawg tau raug txo qis qis dua, lub raum kev ua haujlwm tau zoo heev, thiab cov kev noj qab haus huv muaj txiaj ntsig ntawm kev ntsuas lub neej kuj tau zoo heev.

Avacopan tshuaj qauv

EMA yuav tshuaj xyuas avacopan cov ntawv thov raws li cov kev tswj hwm kev lag luam hauv qhov nruab nrab. Yog tias tau txais kev pom zoo, avacopan yuav tso cai muag hauv txhua EU tus tswv cuab hauv tebchaws raws li Iceland, Liechtenstein thiab Norway. VFMCRP xav tias avacopan yuav pom zoo hauv thawj ib nrab xyoo 2021.

Avacopan yog ib qho tshuaj me me hauv lub qhov ncauj thiab ib qho kev xaiv qhov tso ua kom muaj c5a receptor C5aR1. Los ntawm cov nplaim thaiv kom zoo rau cov receptors rau cov kab mob ua kom muaj qhov tiv thaiv cov kab mob uas tsis haum C5a (C5aR) tam sim no nyob rau saum npoo ntawm kev puas hlwb xws li neutrophils, avacopan tuaj yeem tiv thaiv kev muaj peev xwm ntawm cov hlwb ua rau C5a ua kom, uas yog cov hlab ntsha ntawm ANCA Tus tsav yam mob o. Kev kho Avacopan tsom rau tswj cov txheej txheem vasculitis kom zoo, tiv thaiv kom tsis txhob mob ntxiv, thiab txo kev pheej hmoo ntawm kev kho mob-cuam tshuam. Ntxiv rau, avacopan tsuas yog xaiv tau inhibits C5aR1 kom C5a I txoj hauv kev ua haujlwm nquag dhau los ntawm C5L2 receptor.

Tam sim no, ChemiCentryx tseem tab tom txhim kho avacopan rau kev kho mob ntawm cov neeg mob C3 glomerular kab mob (C3G) thiab zaisradenitis suppurativa (HS). Yav dhau los, Asmeskas FDA tau tso cai rau avacopan lub chaw muag tshuaj muaj npe rau kev kho mob ntawm ANCA-cuam tshuam rau vasculitis, C3G, thiab atypical hemolytic uremic syndrome (aHUS). Hauv European Union, EMA tau tso cai rau avacopan lub chaw tu menyuam cov tshuaj rau kev kho mob C3G thiab ob hom ntawm ANCA vasculitis: granulomatosis nrog polyangiitis (GPA) thiab microscopic polyangiitis (MPA).