Lupkynis Ua Ntawv Thov Rau Npe Hauv EU: Nws Muaj Peev Xwm Zoo Txhim Kho Cov Lus Teb!

Nyiv lub tuam txhab tshuaj Otsuka tsis ntev los no tshaj tawm tias nws cov chaw nyob sab Europe tau xa daim ntawv tso cai ua lag luam (MAA) rau voclosporin mus rau European Lub Chaw Haujlwm Tshuaj (EMA), uas yog qhov ncauj calcineurin inhibitor (CNI), siv los kho tus mob lupus nephritis (LN).

LN yog mob raum hnyav tshwm sim los ntawm tus kab mob autoimmune-systemic lupus erythematosus (SLE), uas sawv cev rau kev loj hlob ntawm SLE. Yog tias tsis muaj kev tswj hwm zoo, nws tuaj yeem ua rau lub raum puas tsuaj thiab tsis hloov pauv, ua rau tus kab mob Raum kawg (ESRD), ua rau muaj kev phom sij rau lub neej. Txawm hais tias tau txais kev kho mob tam sim no rau kev kho mob, kwv yees li ib feem peb ntawm cov neeg mob SLE yuav txhim kho LN, thiab 10-30% ntawm lawv yuav txhim kho ESRD.

voclosporin yog tshuaj tsim los ntawm Aurinia Pharma rau kev kho mob LN theem ob rau SLE. Thaum Lub Kaum Ob Hlis 2020, Otsuka Pharmaceutical thiab Aurinia tau txais kev koom tes thiab daim ntawv tso cai cog lus los tsim thiab lag luam voclosporin los kho LN hauv European Union, Nyij Pooj, Tebchaws Askiv, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein, thiab Ukraine.

Thaum Lub Ib Hlis 2021, voclosporin (lub npe lag luam: Lupkynis) tau pom zoo los ntawm Asmeskas FDA, ua ke nrog cov phiaj xwm kev tiv thaiv kab mob yav dhau los, rau kev kho mob ntawm cov neeg laus uas muaj LN nquag. Thaum Lub Kaum Ob Hlis 2020, GlaxoSmithKline tshuaj tiv thaiv kab mob Benlysta (Belitum, lub npe tshuaj: belimumab, belimumab rau kev txhaj tshuaj) tau pom zoo los ntawm Asmeskas FDA thiab dhau los ua thawj cov tshuaj rau kev kho mob LN. Cov tshuaj no yog qhov tsim nyog rau kev kho mob ntawm cov neeg laus laus uas muaj LN nquag tau txais kev kho mob zoo. Lupkynis yog thawj qhov kev kho qhov ncauj pom zoo los ntawm Asmeskas FDA rau kev kho mob LN.

Benlysta tau pom zoo rau kev lag luam hauv xyoo 2011 thiab yog thawj qhov tshuaj tshiab tau pom zoo rau kev kho mob ntawm kab mob lupus erythematosus (SLE) hauv 50 xyoo dhau los. Hauv Suav Teb, Benlysta (belimumab rau kev txhaj tshuaj) tau pom zoo los ntawm National Food and Drug Administration (NMPA) thaum Lub Xya Hli 2019 los kho cov neeg laus nrog SLE, thiab thaum Lub Kaum Ob Hlis 2020, nws tau pom zoo los ntawm NMPA txhawm rau nthuav qhia cov neeg nyob rau 5- cov neeg mob xyoo. Raws li kev kho mob ib txwm muaj, cov neeg mob uas nquag siv, autoantibody-positive systemic lupus erythematosus (SLE) 5 xyoos thiab laus dua uas tseem muaj kab mob siab ua haujlwm. Kev pom zoo ntawm cov menyuam' cov cim qhia ua rau Benlysta thawj zaug thiab tsuas yog tus neeg sawv cev muaj tshuaj lom uas suav nrog kev kho tus mob SLE rau menyuam yaus thiab cov neeg laus hauv kuv lub tebchaws.

Kev tswj hwm daim ntawv thov ntawm voclosporin yog raws li kev txhawb nqa ntawm txoj haujlwm txhim kho kev kho mob, suav nrog theem tseem ceeb III AURORA txoj kev kawm thiab piv piv theem II AURALV txoj kev tshawb fawb. AURORA yog lub ntiaj teb, tswj cov tshuaj placebo, piv rau Phase III txoj kev kawm. Cov ntaub ntawv qhia tias thaum ua ke nrog mycophenolate mofetil (MMF) thiab qis koob tshuaj corticosteroids hauv qhov ncauj, voclosporin txhim kho kev ua haujlwm ntawm cov neeg mob lupus nephritis piv nrog cov placebo. Kev kwv yees luv-sijhawm thiab mus sij hawm ntev. Cov ntaub ntawv tshwj xeeb yog: Sib piv nrog cov placebo, voclosporin ua rau txhim kho lub raum tshem tawm tus nqi (thawj qhov kawg: 40.8% vs 22.5%, p< 0.001),="" thiab="" tseem="" yog="" cov="" lej="" tseem="" ceeb="" hauv="" txhua="" qhov="" ua="" ntej="" qhov="" tshwj="" xeeb="" hierarchical="" endpoints="" txhim="" kho.="" hauv="" txoj="" kev="" tshawb="" fawb="" no,="" kev="" nyab="" xeeb="" ntawm="" kev="" siv="" tshuaj="" voclosporin="" yog="" piv="" rau="" cov="" txheej="" txheem="" kev="" tswj="">

voclosporin qauv (daim duab qhov chaw: Aurinia)

voclosporin yog qhov tshiab thiab muaj peev xwm tshaj plaws hauv chav kawm calcineurin inhibitor (CNI) nrog cov ntaub ntawv kho mob ntawm ntau dua 2600 tus neeg mob hauv ntau qhov kev qhia. voclosporin yog ib qho tshuaj tiv thaiv kab mob nrog kev sib koom ua ke thiab ob lub tswv yim ntawm kev nqis tes ua. voclosporin ruaj khov raum podocytes los ntawm inhibiting calcineurin (CN), thaiv qhov kev qhia ntawm IL-2 thiab kev tiv thaiv kab mob nruab nrab los ntawm T cells. Piv nrog CNI ib txwm siv, voclosporin muaj kev kwv yees ntau dua ntawm cov tshuaj pharmacokinetic thiab pharmacodynamic kev sib raug zoo (kev saib xyuas tshuaj yuav tsis xav tau), muaj zog ntxiv (piv rau cyclosporin a), thiab txhim kho cov txheej txheem zom zaub mov.

Cov txheej txheem, voclosporin yog qhov sib piv ntawm cyclosporine A (cyclosporine A) nrog kev txuas ntxiv ib leeg-txuas cov pa roj carbon txuas nrog ob npaug nyiaj (ene bond) ntawm ib leeg-carbon saw. voclosporin khi rau cyclophilin A (cyclophilin A) los tsim cov heterodimer complex, uas tom qab ntawd khi thiab txwv tsis pub calcineurin kom ua rau muaj kev tiv thaiv tsis zoo. Kev sib raug zoo ntawm voclosporin thiab cyclosporin A rau tib neeg cyclophilin protein yog sib npaug, tab sis cov ethylenic sab saw ntawm voclosporin tuaj yeem ua rau muaj kev hloov pauv ntawm calcineurin thaum khi, uas tuaj yeem ua rau txhim kho kev tiv thaiv kev ua haujlwm.

Ntxiv rau lupus nephritis (LN), Aurinia tseem tab tom tsim cov suab lus hu ua qhov muag (VOS) rau kev kho qhov muag qhuav (DES). Tam sim no, muaj 3 daim ntawv tso cai los ntawm FDA rau kev kho DES, 2 ntawm yog CNI. VOS muaj peev xwm txhim kho kev kho DES los ntawm kev txo lub sijhawm kom ua tiav lub hom phiaj thiab tus yam ntxwv ntawm DES cov tsos mob thiab cov cim.