Everest Medicines tshaj tawm tias nws tus khub Calliditas Therapeutics AB tshaj tawm tias US Food and Drug Administration (FDA) tau pom zoo TARPEYO™ (budesonide) ncua sij hawm- tso cov tshuaj ntsiav rau txo cov proteinuria hauv cov neeg laus nrog thawj IgA nephropathy uas muaj kev pheej hmoo ntawm kev mob sai sai (feem ntau nrog cov zis ntau dua UPCR) {{3} cov protein ntau dua {{3} los yog sib npaug 1.5 g / g). Qhov kev pom zoo no tau tso cai raws li txoj kev pom zoo nrawm. Nws tseem tsis tau paub meej tias TARPEYO ua rau lub raum tsis ua haujlwm qeeb hauv cov neeg mob IgA nephropathy. Kev pom zoo txuas ntxiv tuaj yeem ua raws li kev txheeb xyuas thiab kev piav qhia ntawm cov txiaj ntsig kho mob hauv qhov kev sim tshuaj xyuas qhov tseeb.
TARPEYO tau pom zoo raws li txoj hauv kev pom zoo nrawm raws li kev sib ntsib thawj qhov kawg ntawm kev txo qis hauv proteinuria hauv Tshooj A ntawm qhov tseem ceeb Theem 3 NeflgArd txoj kev tshawb fawb. Txoj kev tshawb fawb tsis tu ncua yog ib qho randomized, ob npaug - dig muag, placebo- tswj, multicenter sim tsim los ntsuas qhov ua tau zoo thiab kev nyab xeeb ntawm TARPEYO 16 mg ib hnub ib zaug piv nrog cov placebo hauv cov neeg laus nrog thawj IgA nephropathy. TARPEYO tau raug soj ntsuam hauv cov neeg mob biopsy- paub meej tias IgA nephropathy uas muaj eGFR Ntau dua lossis sib npaug li 35 mL / min / 1.73 m², proteinuria Ntau dua lossis sib npaug li 1 g / hnub lossis UPCR Ntau dua lossis sib npaug li 0.8 g / g, thiab tau kho kom ruaj khov ntawm qhov ua tau zoo tshaj plaws.
Thaum Lub Ib Hlis 9, cov neeg mob hauv pawg TARPEYO (n=97) tau ua pov thawj pom qhov tseem ceeb ntawm 34% txo qis hauv cov proteinuria los ntawm lub hauv paus, piv nrog qhov txo qis ntawm 5% hauv cov neeg mob uas tau txais RAS inhibitor ib leeg (n=102). Cov txiaj ntsig kev kho mob ntawm thawj qhov kawg ntawm UPCR ntawm Lub Hlis 9 tau zoo ib yam nyob hauv cov pab pawg tseem ceeb, suav nrog cov pej xeem tseem ceeb thiab cov kab mob hauv paus. Cov kev phiv tshwm sim feem ntau (Ntau dua lossis sib npaug li 5%) hauv txoj kev tshawb no yog kub siab, peripheral edema, nqaij spasms, pob txuv, dermatitis, hnyav nce, dyspnea, lub ntsej muag edema, dyspepsia, qaug zog, thiab hypertrichosis.
