Tsoom Fwv Teb Chaws Asmeskas FDA Pom Zoo Siv Tshuaj Lupkynis Rau Kev Kho Mob Ntawm Cov Neeg Muaj Mob Nrog Cov Neeg Mob Lupus Nephritis (LN).

Aurinia Pharma yog lub tuam txhab kev siv tshuaj biopharmaceutical rau kev tsim kho tshiab rau kev kho mob raum thiab kab mob autoimmune. Tsis ntev los no, lub tuam txhab tshaj tawm tias Asmeskas Chaw Tswj Xyuas Khoom Noj thiab Tshuaj (FDA) tau pom zoo Lupkynis (voclosporin), cov tshuaj tiv thaiv kab mob sib kis tom qab, rau kev kho mob ntawm cov neeg mob laus uas muaj cov mob lupus nephritis (LN).

LN yog ib qho mob hnyav tshaj plaws thiab ib txwm muaj ntawm cov kab mob autoimmune systemic lupus erythematosus (SLE), uas tuaj yeem ua rau lub raum tsis ua haujlwm thiab ua rau lub raum tsis ua haujlwm, mob plawv, thiab tuag.

Thaum Lub Kaum Ob Hlis 2020, GlaxoSmithKline cov tshuaj tiv thaiv tshuaj Benlysta (cov npe tsis tseem ceeb: belimumab) tau pom zoo los ntawm Asmeskas FDA thiab dhau los ua thawj cov tshuaj los kho LN. Lupkynis yog thawj qhov ncauj kho tau pom zoo los ntawm FDA rau kev kho LN.

Hauv kev sim ua piv txwv, cov neeg mob tau txais Lupkynis ua ke nrog cov kev saib xyuas (SoC) kev kho mob muaj peev xwm ntau dua li ob zaug uas yuav ua tiav kev kho lub plawv rov qab dua li cov neeg mob tau txais SoC kev kho mob, thiab tus nqi ntawm cov zis protein-creatinine piv (UPCR) poob qis ntawm qhov tus nqi ntawm tau txais SoC ib txwm kho cov neeg mob ob zaug. UPCR yog ib txoj kev ntsuas kev lag luam uas siv los ntsuas cov qib protein hauv lub raum. Cov kev tiv thaiv thaum ntxov thiab lub raum rov ua dua yog txuam nrog kev ua tau zoo nyob ntev thiab kev tiv thaiv ntawm lub raum tsis ua haujlwm. Cov neeg mob kho nrog Lupkynis pom tias tau txais cov lus teb nce siab hauv txhua qhov ntawm LN ntawm qeb kev tiv thaiv lub cev tsis ua haujlwm.

Lupus nephritis (LN) yog ib qho mob raum mob hnyav los ntawm tus kab mob autoimmune-systemic lupus erythematosus (SLE), uas piv txog kev loj hlob ntawm SLE. Yog tias tsis muaj kev tswj tau zoo, nws tuaj yeem ua rau Irreversible cov ntaub so ntswg mus tas li, ua rau mob rau cov mob raum ntu kawg (ESRD), muaj kev phom sij txog lub neej.

Thaum Lub Kaum Ob Hlis 2020, GlaxoSmithKline Benlysta tau pom zoo los ntawm Asmeskas FDA raws li thawj lub tshuaj kho LN. Cov tshuaj no haum rau kev kho mob ntawm cov neeg laus cov neeg laus LN uas tau txais kev kho mob. Benlysta tau pom zoo rau kev lag luam hauv xyoo 2011 thiab yog thawj cov tshuaj tshiab pom zoo rau kev kho mob ntawm kab mob lupus erythematosus (SLE) hauv 50 xyoo dhau los. Hauv Suav teb, Benlysta (Benlysta, belimumab rau kev txhaj tshuaj) tau pom zoo thaum Lub Xya Hli 2019. Raws li lub ntiaj teb' s thawj cov neeg sawv cev tau pom zoo rau kev kho mob ntawm SLE, Britton tau pom zoo hauv Suav teb los ua ke nrog kev kho mob sib xyaw, uas yog haum rau cov neeg mob siab thiab autoantibody-zoo rau cov neeg laus nrog SLE uas tseem muaj cov kab mob siab rau kev ua haujlwm raws li kev kho mob.

Kev pom zoo ntawm lub qhov ncauj tshuaj Lupkynis yog ua raws li kev txhawb nqa ntawm ib qho kev tsim kho hauv tsev kho mob, suav nrog rau kev kawm qib III AURORA kev kawm thiab qhov piv piv theem II AURALV. AURORA yog txoj kev kawm thoob ntiaj teb, siv cov chaw tso khoom, piv rau theem III. Cov ntaub ntawv qhia tau hais tias thaum ua ke nrog mycophenolate mofetil (MMF) thiab kev noj tshuaj tsawg dua hauv lub qhov ncauj, voclosporin txhim kho kev ua haujlwm ntawm cov neeg mob lupus nephritis piv nrog cov placebo. Kev kawm ib ntus luv thiab ntev. Cov ntaub ntawv tshwj xeeb yog: Sib piv nrog cov placebo, voclosporin muaj ntau ntxiv lub raum kev zam rov qab (thawj qhov kawg: 40.8% vs 22.5%, p< 0.001),="" thiab="" tseem="" muaj="" cov="" ntaub="" ntawv="" tseem="" ceeb="" hauv="" txhua="" qhov="" kev="" npaj="" tseg="" yav="" dhau="" los="" kom="" zoo="" dua="" qub.="" hauv="" qhov="" kev="" tshawb="" fawb="" no,="" kev="" nyab="" xeeb="" ntawm="" kev="" ua="" noj="" ntawm="" voclosporin="" yog="" piv="" rau="" cov="" qauv="" kev="" coj="">

voclosporin qauv

voclosporin yog cov tshuaj tshawb pom, uas yog qhov tshiab thiab muaj peev xwm zoo tshaj plaws hauv chav calcineurin inhibitor (CNI) nrog cov ntaub ntawv soj ntsuam ntau dua 2600 tus neeg mob hauv ntau qhov ntsuas. voclosporin yog ib qho tshuaj tiv thaiv kab mob nrog ib tus synergistic thiab dual mechanism ntawm kev ua. voclosporin stabilizes raum podocytes los ntawm inhibiting calcineurin (CN), thaiv cov IL-2 qhia thiab T cell-mediated lub cev tiv thaiv tsis tau. Piv nrog rau CNI ib txwm muaj, voclosporin muaj kev paub tseeb ntau dua pharmacokinetic thiab pharmacodynamic kev sib raug zoo (tshuaj saib xyuas tshuaj tsis tas yuav tsum tau), muaj ntau zog ntxiv (piv rau cyclosporin a) thiab txhim kho cov teeb meem metabolic.

Cov txheej txheem, voclosporin yog ib qho sib piv ntawm cyclosporine A (cyclosporine A) nrog ib qho txuas ntxiv cov pa roj carbon txuas ntxiv nrog ob daim ntawv cog lus (ene bond) ntawm cov pa roj carbon ib leeg. voclosporin khi rau cyclophilin A (cyclophilin A) los ua cov kab mob heterodimeric complex, uas tom qab ntawd khi thiab inhibits calcineurin tawm kev cuam tshuam ntawm cov tshuaj tiv thaiv immunosuppressive. Txoj hlua khi sib xyaw ntawm voclosporin thiab cyclosporin A rau tib neeg cov protein cyclophilin yog qhov sib npaug, tab sis sab caj npab ethylnic cov saw ntawm voclosporin tuaj yeem tsim cov kev hloov pauv ntawm calcineurin thaum khi, uas yuav ua rau muaj kev tiv thaiv kab mob ntxiv.

Ntxiv rau qhov mob lupus nephritis (LN), Aurinia tseem tab tom pib tsim cov tshuaj muag qhov muag (VOS) rau kev kho qhov muag qhuav (DES). Tam sim no, muaj 3 FDA tshuaj pom zoo muab tshuaj rau kev kho mob ntawm DES, 2 ntawm ntawd yog CNI. VOS muaj qhov zoo los txhim kho kev kho mob ntawm DES los ntawm kev txo lub sijhawm kom ua tiav lub hom phiaj thiab kev cia siab rau DES cov tsos mob thiab cov paib.