Tus tshiab-hauv-chav calcineurin inhibitor voclosporin yog thov rau kev tso npe hauv Tebchaws Asmeskas!

Aurinia Pharma yog lub tuam txhab kev siv tshuaj biopharmaceutical los tsim kho tshiab rau cov mob raum thiab cov kab mob autoimmune. Tsis ntev los no, lub tuam txhab tshaj tawm tias nws tau ua tiav qhov kev xa cov ntawv thov siv tshuaj tshiab (NDA) rau voclosporin los kho tus mob lupus nephritis (LN) rau Asmeskas Chaw Tswj Khoom Noj thiab Tshuaj (FDA). Sij hawm dhau los, FDA tau tso cai rau cov txheej txheem kev ua haujlwm sai (FTD) rau kev kho LN. Kev xa tawm NDA suav nrog kev thov rau kev txheeb xyuas qhov tseem ceeb. Yog tias tso cai, FDA tshuaj xyuas lub sijhawm rau NDA yuav raug luv rau 8 lub hlis txij hnub xa, thaum lub sijhawm tshuaj xyuas cov qauv yog 12 hli.

Lupus nephritis (LN) yog ib qho mob raum ntau heev los ntawm tus kab mob autoimmune systemic lupus erythematosus (SLE), uas sawv cev rau kev loj hlob ntawm SLE. Yog tias nws tsis tswj tau zoo, nws tuaj yeem ua rau tas mus li, kev puas tsuaj rau cov ntaub so ntswg ua rau lub raum mob raum thaum kawg (ESRD), uas ua rau tuag taus. Tam sim no, tsis muaj FDA pom zoo kho rau LN.

Voclosporin muaj feem yuav los ua thawj cov tshuaj pom zoo los ntawm FDA los kho tus mob lupus nephritis (LN). Lub NDA rau cov tshuaj no yog ua raws li kev txhawb nqa ntawm ib qho kev tsim kho mob, nrog rau cov theem tseem ceeb III AURORA kev kawm thiab qib tseem ceeb II AURARV txoj kev tshawb nrhiav.

Aurinia Thawj Tswj Hwm thiab CEO Peter Greenleaf tau hais tias:" Lupus nephritis yog mob hnyav thiab tsis zoo ntawm cov mob lupus, thiab nws yuav cuam tshuam loj rau lub neej zoo ntawm cov tib neeg uas tawm tsam lupus. Pab pawg neeg ntawm Aurinia tseem niaj hnub sib zog ua haujlwm coj cov neeg mob LN Thawj qhov kev npaj kho mob tau pom zoo los ntawm FDA, uas xav tias yuav pauv LN. Peb cov chaw kho mob dav, suav nrog cov txiaj ntsig ntawm AURA thiab AURORA cov kev sim, muab kev txhawb nqa zoo rau cov tshuaj voclosporin uas yog kev kho tus mob ntawm lupus nephritis. Peb tau txhim kho kom sai sai rau peb Asmeskas cov tswv yim kev lag luam thiab kho vaj tse kom txhawb nqa cov khoom lag luam uas tuaj yeem pib lub xyoo tom ntej."

Lawrence Mandt, Aurinia tus lwm thawj kws tshaj lij rau kev tswjhwm kev ua haujlwm zoo thiab tshaj lij, tau hais tias: "Cov Kev Ntsuam Xyuas tau zoo nyob ntev III tau ua rau cov kws tshaj lij ntawm Aurinia tau tsim thiab xa cov lus tshaj tawm zoo rau voclosporin ua ntej peb cov kev cia siab. Tam sim no peb tab tom nrhiav rau yav tom ntej Lub hlis tom ntej sib tham nrog FDA txog hnub lees txais cov ntawv thov thiab kev tshuaj xyuas ua ntej thiab tau txais kev pom zoo thaum ntxov 2021."

tus qauv voclosporin (Cov duab ntawm: Aurinia)

voclosporin yog ib qho tshuaj tshawb, uas yog ib qho tshiab, muaj peev xwm zoo tshaj plaws hauv chav calcineurin inhibitor (CNI) nrog cov ntaub ntawv soj ntsuam rau ntau dua 2, 600 cov neeg mob hauv ntau qhov ntsuas. voclosporin yog cov tshuaj tiv thaiv kab mob nrog 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 tsis muaj zog. Piv nrog rau CNI ib txwm muaj, voclosporin muaj kev kwv yees ntau dua qhov tseeb ntawm kev sib raug zoo thiab pharmacodynamic (tej zaum yuav tsis tas tshuaj tshuaj), ua kom muaj txiaj ntsig zoo (piv rau cyclosporin a) thiab txhim kho cov teeb meem metabolic.

Kev sib txuas, voclosporin yog ib qho khoom sib piv ntawm cyclosporine A (cyclosporine A) nrog rau cov kab txuas ntxiv txuas ntxiv cov pa roj carbon txuas nrog ob daim ntawv cog lus (alkene bond) ntawm cov pa roj carbon ib leeg. voclosporin thiab cyclophilin A (cyclophilin A) muab sib xyaw los ua cov kab mob heterodimeric complex, uas tom qab ntawd khi thiab tso cov tshuaj calcineurin tawm los ua kom cov nyhuv immunosuppressive. Kev khi qhov sib thooj ntawm voclosporin thiab cyclosporin A rau tib neeg cov protein cyclophilin yog qhov sib piv, tab sis sab qauv sib tshooj ntawm voclosporin tuaj yeem ua rau cov kev hloov pauv hauv calcineurin raws li kev cog lus, uas yuav ua rau muaj kev tiv thaiv kab mob sib kis ntxiv.

Aurinia cia siab tias raws li Hatch-Waxman Txoj Cai thiab cov cai sib xws hauv lwm lub teb chaws, tom qab tau txais kev pom zoo kev cai, kev tiv thaiv patent ntawm voclosporin hauv Tebchaws Meskas thiab lwm yam kev lag luam loj (suav nrog Europe thiab Nyij Pooj) yuav txuas ntxiv mus tsawg kawg thaum Lub Kaum Hli 2027, lub sijhawm tiv thaiv patent rau cov cim qhia menyuam yaus xav tias yuav ncua sijhawm rau Lub Plaub Hlis 2028. Ib qho ntxiv, yog tias FDA suav nrog kev noj tshuaj kom zoo uas siv hauv AURA thiab AURORA cov kev sim hauv cov khoom lag luam, US daim ntawv cog lus zais npog cov txheej txheem kev noj tshuaj ntawm voclosporin yuav txuas ntxiv lub sijhawm tiv thaiv cov khoom kom txog lub Kaum Ob Hlis 2037.

Tam sim no, Aurinia tau ua tiav qhov kev tshawb fawb nyob qib III (AURORA) ntawm voclosporin kho mob lupus nephritis. Qhov no yog thoob ntiaj teb, placebo-tswj, qhov tseem ceeb theem III kawm. Cov ntaub ntawv qhia tau hais tias thaum ua ke nrog mycophenolate mofetil (MMF) thiab kev noj tshuaj tsawg lub qhov ncauj corticosteroids, voclosporin txhim kho kev ua tau zoo ntawm cov neeg mob lupus nephritis piv rau cov placebo. Kev sojntsuam ncua sijhawm luv thiab ntev. Cov ntaub ntawv tshwj xeeb yog: piv nrog cov placebo, voclosporin txhim kho lub raum rov qab zoo dua (thawj qhov xaus: 40. {{5}}% vs 22. 5% , p< 0.="" hauv="" cov="" kev="" tshawb="" fawb="" no,="" kev="" nyab="" xeeb="" ntawm="" cov="" txheej="" txheem="" voclosporin="" piv="" rau="" cov="" qauv="" txheej="">

Ntxiv nrog rau qhov mob lupus nephritis (LN), Aurinia tseem tab tom pib txhim kho voclosporin qhov muag (VOS) rau kev kho qhov muag qhuav (DES). Tam sim no, muaj peb FDA tshuaj pom zoo muab tshuaj rau kev kho mob ntawm DES, ob qho ntawm 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 phiajcim.