Novartis ntau yam sclerosis tshuaj Sinimod ntsiav tshuaj yog li yuav tau txais kev pom zoo hauv Suav teb

Tsis ntev los no, daim ntawv thov rau cov npe ntawm Novartis Nimod Films (Txais Tsis Tau.: JXHS 1900028, 29) tau raug hloov mus rau" raws li kev soj ntsuam" thiab yuav tsum raug pom zoo kom tso npe nyob rau yav pem suab. Sinimod yog cov tshuaj siv los kho ntau tus sclerosis. Nws tau pom zoo los ntawm FDA hauv lub Peb Hlis 2019. Thaum Lub Xya Hli 2019, Novartis' lwm qhov tshuaj MS hnyav hnyav Fingomo tau tsim tawm hauv Tebchaws Yelemees.

Kev pom zoo los ntawm FDA hauv lub Peb Hlis 2019

Sinimod (Siponimod, lub npe lag luam: Mayzent) yog lub cim tshiab ntawm kev xaiv sphingosine - {{1}} - phosphate (S {{1}} P) receptor modulator tsim los ntawm Novartis, uas tuaj yeem khi rau S {{1}} P {{1}} subtype receptors nyob rau hauv lymphocytes los tiv thaiv Lawv nkag mus rau hauv nruab nrab lub paj hlwb (CNS) ntawm cov neeg mob uas muaj ntau yam sclerosis (MS), yog li kev tswj hwm kev mob o.

Cov kev tshawb fawb pom tau tias Cinimod tuaj yeem tiv thaiv qhov mob neurodegenerative lesions ntawm cov lus sib tshooj thiab txhawb qhov myelination ntawm CNS. Nws muaj peev xwm hloov mus rau hauv chav kawm ntawm tus kabmob. Thaum Lub Peb Hlis 2019, nws tau pom zoo los ntawm Asmeskas FDA rau cov tshuaj noj ntawm qhov ncauj, suav nrog 0. 25 mg thiab 2 mg, rau kev kho mob rau cov neeg mob laus uas rov mob ntau yam sclerosis (RMS), suav nrog cov mob uas rov huam tuaj dua Thiab muaj tus kab mob ntxiv mus (activeSPMS).

Lub Ob Hlis 2019, CDE tau lees txais cov ntawv thov kev lag luam ntawm Cinimod ntsiav tshuaj, thiab cov tshuaj tom qab tau suav nrog cov txheej txheem tshuaj xyuas kev ua ntej. Lub sijhawm no nws tau pom zoo zoo, tsuas yog li ib xyoos ntawm Tebchaws Meskas. Thaum Lub Tsib Hlis 2018, ntau tus sclerosis (MS) tau suav nrog hauv Suav Teb' s" Thawj Daim Ntawv Tshaj Tawm Tsis Muaj Kab Mob." Kev pom zoo ntawm Sinimod cia siab tias yuav coj cov kev kho mob tshiab rau pawg neeg mob no.

Cov ntaub ntawv tshiab kawg ntawm Sinimod zaj duab xis tau luam tawm nyob rau lub Plaub Hlis 2020 phau ntawv xov xwm ntxiv ntawm Asmeskas Academy ntawm Neurology kev kho mob phau ntawv xov xwm" Neurology" ;. Cov ntaub ntawv no yog saib raws li cov pov thawj hauv tsev kho mob: Hauv cov neeg mob uas muaj mob ntau yam sclerosis (SPMS), Mayzent tau pom tias ua rau muaj kev xiam oob qhab qeeb ntawm lub cev thiab muab cov txiaj ntsig kev txawj ntse. Cov ntaub ntawv los ntawm 5-xyoo EXPAND qhib daim ntawv lo txuas ntxiv mus sib hais luam tawm lub sijhawm no tau los ntsuas kev ua haujlwm ntev thiab kev nyab xeeb ntawm Mayzent hauv SPMS cov neeg mob. Cov ntaub ntawv tau qhia tias piv rau cov pab pawg placebo-hloov, cov neeg mob hauv pawg Mayzent tsis tshua pom tseeb tias muaj kev tsis taus (CDP) ntawm 3 thiab 6 hli (feem: p=0. {{ 7}} thiab p=0. 0048), uas hais txog thaum ntxov ntawm qhov zoo ntawm kev kho. Cov ntaub ntawv tshiab tseem tau qhia tias pawg Mayzent tau muaj 52 feem pua ​​txo qis hauv cov kev rov ua haujlwm txhua xyoo (ARR) piv rau cov pab pawg placebo-pawg (p< 0.="" 0001).="" muab="" piv="" nrog="" cov="" pab="" pawg="" placebo-hloov,="" qhov="" kev="" pheej="" hmoo="" ntawm="" kev="" ua="" tsis="" zoo="" rau="" cov="" neeg="" tsis="" paub="" (kuaj="" raws="" li="" lub="" cim="" qauv="" qauv)="" lees="" paub="" los="" ntawm="" mayzent="" pawg="" ntawm="" 6="" lub="" hlis="" raug="" txo="" los="" ntawm="" 23%="" (p="0." {="" {18}}).="" cov="" txiaj="" ntsig="" kho="" mob="" tau="" pom="" los="" ntawm="" pawg="" mayzent="" tau="" kav="" ntev="" txog="" 5="" xyoo,="" qhia="" txog="" qhov="" zoo="" ntawm="" kev="" kho="" thaum="">

Kev tshawb nrhiav siab thiab nthuav dav muaj txiaj ntsig, kev muag txhua xyoo ntawm cov tshuaj muag tau zoo tshaj plaws txog 4. 4 billion Asmeskas las

Ntau tus kab mob sclerosis (MS) yog ib qho kev tiv thaiv kab mob kev tiv thaiv kab mob ua mob rau cov leeg hlwb, feem ntau cuam tshuam nrog cov leeg, ze rau cortex, optic hlab ntsha, txha caj qaum, hlwb qia thiab cerebellum. Thiab cov yam ntxwv ntawm lub sijhawm tsis tu ncua. Qhov xwm txheej thiab kev nthuav dav muaj cuam tshuam nrog thaj chaw faib thiab haiv neeg. Cov chaw muaj ntau qhov chaw muaj xws li Tebchaws Europe, Southern Canada, North America, New Zealand, thiab Southeast Australia, nrog rau kev tshwm sim ntawm 60 / 100, 000-300 / 100, 000; Cov teb chaws Asian thiab African muaj qhov qes dua, txog 5 / 100, 000; Tuam Tshoj yog qis Nyob hauv thaj chaw muaj kev cuam tshuam, kev tshwm sim zoo ib yam yuav zoo ib yam li Nyij Pooj.

MS-Chronic inflammatory demyelinating kab mob ntawm cov hlab ntsha nruab nrab

MS tau muab faib ua 4 subtypes, thiab txhua subtype nws muaj nws tus yam ntxwv.

Tsis muaj ib txoj hauv kev kho zoo rau MS, thiab chaw kho mob tseem ua raws cov kev hloov kho kabmob (DMT). Cov tshuaj rau kev kho mob MS feem ntau muab faib ua peb pawg: tshuaj tiv thaiv kab mob, immunosuppressants thiab tshuaj tiv thaiv.

Daim ntawv 2019 ntawm" Kev tshuaj xyuas thiab Kho Cov Lus Qhia rau Cov Kab Mob Tsis tshua Txaus" hauv Suav pom zoo rau 13 cov tshuaj thoob ntiaj teb, xws li interferon (txhaj tshuaj), glimeramide (txhaj tshuaj), ntiv tes ntiv tes (qhov ncauj), teriflunomide (qhov ncauj), Dimethyl fumarate (qhov ncauj), natalizumab (txhaj), alemtuzumab (txhaj), aurizumab (txhaj tshuaj), mitoxantrone (txhaj tshuaj), thiab lwm yam Ntawm lawv, interferon (IFNβ) thiab glatimer acetate (Glatiramer acetate, lub npe lag luam: Copaxone) yog thawj cov tshuaj tua kab mob rau rov mob MS, uas yog tswj los ntawm txhaj tshuaj subcutaneous los yog txhaj tshuaj rau. Natalizumab (Natalizumab, lub npe lag luam: Tysabri) thiab mitoxantrone (Mitoxantrone, lub npe lag luam: Novantrone) yog siv tshuaj kho kab mob thib ob thiab xav kom tso ntshav nrog kev pab los ntawm cov kws kho mob.

Vim tias MS ua rau muaj mob ntev yuav tsum tau noj tshuaj kho mob mus ntev, cov neeg mob muaj peev xwm xav tau cov tshuaj noj ntawm qhov ncauj. Tam sim no, muaj 4 qhov ncauj MS tshuaj nyob rau hauv lub ntiaj teb ua lag luam, uas yog Fingolimod Hydrochloride (npe lag luam: Gilenya), Teriflunomide (npe lag luam: Aubagio) thiab Dimethyl Fumarate (Dimethyl Fumarate, Lub npe Lag Luam: Tecfidera) thiab Sinimod (Siponimod) , lub npe lag luam tawm: Mayzent).

Nyob nruab nrab ntawm 2010 thiab 2020, rau 6 lub tshuaj tau tsim tawm, nrog lub hom phiaj suav nrog Nrf 2, SIPR, thiab CD 2 0. Ntawm lawv, dimethyl fumarate muag tau qhov zoo tshaj plaws, nrog kev muag khoom thoob ntiaj teb tau txog US $ 4. 44 nphom hauv 2 019, nce xyoo ntawm 4. 0 %.