Bristol-Myers Squibb ntau yam sclerosis tshuaj Zeposia (ozanimod) tau pom zoo los ntawm Asmeskas FDA!

Bristol-Myers Squibb (BMS) tsis ntev los no tshaj tawm tias Tsoomfwv Meskas Khoom Noj thiab Tshuaj (FDA) tau pom zoo Zeposia (ozanimod, 0.92 mg) rau kev kho mob ntawm cov neeg laus rov mob ntau yam sclerosis (RMS), suav nrog cov chaw kho mob sib kis mob sib kis mob sib luag, kev ua mob loj thib ob kab mob. Zeposia yog qhov ncauj noj tshuaj uas noj ib hnub ib zaug. Cov tshuaj yog tsuas yog pom zoo sphingosine-1-phosphate (S1P) receptor modulator nrog cov yam ntxwv li nram no: thaum tus neeg mob RMS pib kho, tsis tas yuav kuaj caj ces thiab tsis tas kuaj daim ntawv' s thawj koob tshuaj xyuas. Vim tias tseem muaj qhov txo qis me ntsis ntawm lub plawv dhia thiab atrioventricular conduction qeeb, cov koob tshuaj txij nkawm ntawm Zeposia yuav tsum ua tiav los ntawm cov txheej txheem sab sauv.

Zeposia tau tsim los ntawm Xinji, uas yog thawj qhov kev thov tshuaj tshiab (NDA) tau pom zoo los ntawm Asmeskas FDA txij li Bristol-Myers Squibb' s nrhiav tau ntawm Xinji, uas yuav nthuav Bristol-Myers Squibb' s franchise hauv teb ntawm immunology. Tam sim no, Zeposia' s daim ntawv thov tso cai kev lag luam (MAA) tau raug tshuaj xyuas los ntawm European Medicines Agency (EMA), thiab nws cia siab tias cov txiaj ntsig yuav tau txais nyob rau thawj ib nrab ntawm 2020.

Ntau yam sclerosis (MS) yog ib yam kab mob uas lub nruab nrog cev tiv thaiv tus kabmob tiv thaiv myelin npog cov hlab ntsha hauv lub cev, ua rau lub cev puas tsuaj thiab ua rau nws nyuaj rau cov cim kis tau ntawm txhua tus xovtooj ntawm lub paj hlwb. No" co tes sib tsoo" tuaj yeem ua rau cov tsos mob tshwm sim thiab rov huam dua.

Zeposia' s nquag ua tshuaj sib xyaw ozanimod yog qhov ncauj S1P receptor modulator uas xaiv khi S1P1 thiab S1P5 nrog qhov siab zoo. Qhov kev xaiv khi ntawm ozanimod mus rau S1P1 ntseeg tau tias yuav ua rau muaj kev txwv tsis pub hloov mus rau ib qho tshwj xeeb ntawm kev ua haujlwm ntawm lymphocytes mus rau thaj chaw mob, txo cov qib ntawm cov ntshav tawm T lymphocytes thiab B lymphocytes uas tuaj yeem ua rau cov dej num tiv thaiv kev tiv thaiv, thiaj li ua rau muaj zog tiv thaiv kab mob. zuj zuj txoj hlab ntshav myelin sheath. Vim yog lub tshuab tshwj xeeb ntawm kev ua haujlwm ntawm ozanimod, tus neeg mob' s kev soj ntsuam lub cev tsis tuaj yeem tswj tau. Kev sib xyaw ntawm ozanimod thiab S1PR5 tuaj yeem ua kom cov hlwb tshwj xeeb hauv lub hauv nruab nrab cov hlab ntsha, txhawb txoj kev tsim kho myelin, thiab tiv thaiv kom txhob muaj qhov teeb meem synaptic, uas thaum kawg tuaj yeem tiv thaiv cov leeg puas. Raws li kev sib koom ua ke ntawm" txo kev puas tsuaj + txhim kho kev kho" ;, ozanimod muaj lub peev xwm los txhim kho cov tsos mob ntawm ntau cov kab mob tiv thaiv kab mob.

Zeposia' s kev pom zoo yog saib raws cov ntaub ntawv los ntawm qhov loj tshaj, qhov tseem ceeb, lub taub hau rau RMS kawm txog hnub tim: kev tshawb fawb, kev soj ntsuam tshuaj zoo nyob rau theem III kev tshawb fawb SUNBEAM thiab RADIANCE Tshooj B. Hauv ob txoj kev tshawb nrhiav no, Zeposia qhia ib cov nyhuv tseem ceeb piv nrog Avonex (interferon inter-1a) hais txog kev rov ua dua txhua xyoo (ARR), qhov ntsuas tseem ceeb ntawm kev ua haujlwm ntawm tus kabmob. Cov ntaub ntawv tshwj xeeb yog: piv nrog Avonex, Zeposia txo ARR los ntawm 48% rau ib xyoos (tsis haum ARR: 0.18 vs 0.35), thiab txo ARR los ntawm 38% rau ob xyoos (meej ARR: 0.17 vs 0.28).

Tsis tas li ntawd, piv rau Avonex, Zeposia kuj tseem txo cov xov tooj ntawm lub hlwb thiab qhov loj ntawm lub qhov txhab. Cov ntaub ntawv tshwj xeeb yog: ib xyoos ntawm kev kho mob, Zeposia txo cov T1-nyhav nyhav gadolinium-txhim kho (GdE) lub hlwb puas (0.16 vs 0.43) los ntawm 63% piv rau Avonex, thiab txo tus lej ntawm qhov tshiab lossis nthuav T2 qhov kev raug mob (1.47 vs 2.84) Tus kwv yees txo los ntawm 48%. Tom qab ob xyoos ntawm kev kho mob, Zeposia tau txo qis ntawm T1-nyhav nyhav gadolinium-txhim kho (GdE) lub hlwb raug mob (0.18 vs 0.37) los ntawm 53% piv rau Avonex, thiab txo tus lej ntawm qhov tshiab lossis nthuav dav T2 kev raug mob (1.84 vs 3.18) 42 %. Hauv ob xyoos ntawm kev kho mob, tsis muaj hnub nyoog dab tsi sib txawv hauv kev nce qib ntawm kev xiam oob qhab nruab nrab ntawm 3 thiab 6 lub hlis ntawm Zeposia thiab Avonex pawg kho mob. Hauv 2 kev tshawb nrhiav, Zeposia pom tias muaj kev nyab xeeb thiab thev taus.

Ntau yam sclerosis (MS) yog ib hom mob raum ua rau lub nruab nrog cev txhawm rau ua mob rau tus neeg 2.3 lab tus neeg thoob ntiaj teb thiab cuam tshuam rau ntau tus poj niam ntau dua li tus txiv neej. Tus kab mob yog tus cwj pwm los ntawm demyelination thiab poob ntawm axons, uas ua rau lub cev tsis muaj zog thiab kev ua tsis taus. Lub ntsiab subtype ntawm MS yog rov ua ntau yam mob sclerosis (RMS), xam txog 85% ntawm cov neeg mob MS, suav nrog cov neeg mob sib cais (CIS), rov mob-kho ntau yam mob sclerosis (RRMS) thiab kev ua mob mus rau lwm qhov ntau yam Sclerosis (SPMS). Rov qab txhais tau tias yog tus mob tshiab, phem dua, los yog mob tshwm sim ntev dua 24 teev yam tsis muaj kub taub hau los yog kis tau. Kev rov huam mob tuaj yeem daws tau tag nrho nyob rau hauv ob peb hnub lossis ob peb asthiv, lossis nws tuaj yeem ua rau muaj kev nthuav dav ntau ntxiv rau qhov ua tsis taus thiab xiam oob qhab.

Tam sim no, sphingosine-1-phosphate (S1P) receptors tau dhau los ua lub hom phiaj tseem ceeb hauv kev txhim kho cov tshuaj tshiab hauv thaj teb MS. Thaum Lub Peb Hlis 2019, Novartis Mayzent (siponimod) tau pom zoo los ntawm Asmeskas FDA rau kev kho mob ntawm cov neeg mob RMS, suav nrog cov theem nrab ntawm ntau tus mob sclerosis (SPMS), rov tshwm sim-kho ntau yam sclerosis (RRMS), kev kho mob Solitary syndrome (CIS). Nws tsim nyog teev tias Mayzent yog thawj qhov tshuaj kho mob tshwj xeeb uas tau pom zoo rau cov neeg mob nrog SPMS hauv 15 xyoos dhau los. Mayzent' s cov tshuaj ua haujlwm zoo yog siponimod, uas yog lub cim tshiab, xaiv sphingosine-1-phosphate (S1P) receptor modulator uas tuaj yeem xaiv sib cuam tshuam nrog S1P receptor 1 (S1P1) thiab receptor 5 (S1P5) Kev sib xyaw, lub tshuab ntawm kev ua yog tib yam li ntawm Zeposia ntawm Bristol-Myers Squibb.

Tom qab Zeposia tsim tawm, nws yuav ntsib kev sib tw los ntawm ntau yam tshuaj ntawm qhov ncauj, xws li Novartis 'Gilenya thiab Mayzent, Sanofi's Aubagio, Bojian's Tecfidera thiab Vumerity, Merck' s Mavenclad, thiab Roche's antibody tsuas xav tau infused ob zaug nyob rau ib xyoo Qhov tshuaj Ocrevus. Ntxiv rau ntau yam mob sclerosis, ozanimod tseem tab tom raug tsim los ntawm ntau cov tshuaj tiv thaiv kab mob, nrog rau mob ncauj plab (UC) thiab Crohn' s kab mob (CD).

Nws tsim nyog teev tias tsuas yog lub lim tiam dhau los, Johnson& Johnson tau xa daim ntawv thov cov tshuaj tshiab (NDA) ntawm ponesimod los kho cov neeg mob laus uas rov mob ntau yam sclerosis (RMS) rau Asmeskas FDA. Cov tshuaj no yog cov tshiab, lub qhov ncauj, xaiv S1P1 kev cai Tus neeg sawv cev tuaj yeem cuam tshuam kev ua haujlwm ntawm S1P protein. Hauv thawj qhov loj-tswj tau lub taub hau-rau-lub taub hau theem III OPTIMUM kev kawm (NCT02425644) ntsuas cov tshuaj ob lub qhov ncauj rau RMS, kev ua tau zoo ntawm ponesimod yeej Sanofi tshuaj Aubagio (teriflunomide, teriflunomide). Qhov kev lag luam-ua qhov ncauj RMS tshuaj tau muag rau ntau tshaj 70 lub teb chaws thoob ntiaj teb. Hauv Suav Teb, Aubagio (Aubagio) tau pom zoo rau cov npe thaum Lub Xya Hli 2018, thiab yog thawj cov tshuaj kho qhov ncauj kho mob tau pom zoo rau kev kho mob ntau yam txha caj qaum hauv Suav.