Rezdiffra (resmetirom) tau txais kev pom zoo los ntawm FDA ntawm Tebchaws Meskas rau kev kho cov neeg laus uas tsis muaj dej cawv tsis muaj dej cawv steatohepatitis (NASH) nrog rau nruab nrab mus rau siab siab caws pliav (fibrosis), siv nrog rau kev noj haus thiab kev tawm dag zog.
Txog rau tam sim no, cov neeg mob uas tsis muaj dej cawv tsis muaj cawv steatohepatitis (NASH) uas tseem muaj qhov caws pliav ntawm daim siab tsis muaj tshuaj uas tuaj yeem hais ncaj qha rau lawv. lub siab puas. FDA tus kev pom zoo ntawm Rezdiffra yuav, thawj zaug, muab a kev kho mob kev xaiv rau cov neeg mob no, ntxiv rau kev noj haus thiab kev tawm dag zog.
NASH yog qhov tshwm sim los ntawm kev nce qib ntawm cov rog uas tsis muaj cawv nplooj siab kab mob qhov twg nplooj siab o, dhau sijhawm, tuaj yeem ua rau daim siab caws pliav thiab daim siab ua haujlwm tsis zoo. NASH feem ntau cuam tshuam nrog lwm yam teeb meem kev noj qab haus huv xws li ntshav siab thiab ntshav qab zib hom 2. Los ntawm tsawg kawg ib qho kev kwv yees, kwv yees li 6-8 lab tus tib neeg hauv Teb Chaws Asmeskas muaj NASH nrog rau nruab nrab mus rau siab heev daim siab caws pliav, nrog tus lej ntawd yuav nce ntxiv.
Rezdiffra yog ib feem activator ntawm cov thyroid hormone receptor; Ua kom cov receptor no los ntawm Rezdiffra nyob rau hauv daim siab txo cov rog rog.
Kev nyab xeeb thiab kev ua tau zoo ntawm Rezdiffra
Kev nyab xeeb thiab kev ua tau zoo ntawm Rezdiffra tau soj ntsuam raws li kev soj ntsuam ntawm tus neeg sawv cev qhov kawg ntawm lub hli 12 hauv 54-hli, randomized, ob qhov muag tsis pom kev placebo-tswj sim. Tus surrogate endpoint ntsuas qhov twg nplooj siab o thiab caws pliav. Tus neeg txhawb nqa yuav tsum tau ua txoj kev tshawb fawb tom qab kev pom zoo los txheeb xyuas thiab piav qhia txog Rezdiffra cov txiaj ntsig kho mob, uas yuav ua tiav los ntawm kev ua tiav tib txoj kev tshawb fawb 54 lub hlis, uas tseem tab tom ua. Txhawm rau tso npe rau hauv qhov kev sim, cov neeg mob yuav tsum muaj ib qho nplooj siab biopsy uas qhia o vim NASH nrog nruab nrab lossis siab heev nplooj siab caws pliav. Hauv kev sim, 888 cov ntsiab lus tau muab tso ua ke kom tau txais ib qho ntawm cov hauv qab no: placebo (294 yam); 80 milligrams ntawm Rezdiffra (298 yam); los yog 100 milligrams ntawm Rezdiffra (296 yam); ib hnub ib zaug, ntxiv rau kev saib xyuas tus qauv rau NASH, uas suav nrog kev tawm tswv yim rau kev noj zaub mov zoo thiab kev tawm dag zog.
Thaum 12 lub hlis, daim siab biopsies tau pom tias ntau dua ntawm cov kev kawm uas tau kho nrog Rezdiffra tau ua tiav NASH kev daws teeb meem lossis kev txhim kho daim siab caws pliav piv nrog cov neeg tau txais cov placebo. Tag nrho ntawm 26% mus rau 27% ntawm cov neeg uas tau txais 80 milligrams ntawm Rezdiffra thiab 24% mus rau 36% ntawm cov neeg uas tau txais 100 milligrams ntawm Rezdiffra tau ntsib NASH daws teeb meem thiab tsis ua rau daim siab caws pliav, piv rau 9% mus rau 13% ntawm cov neeg uas. tau txais cov placebo thiab kev sab laj txog kev noj zaub mov thiab kev tawm dag zog. Qhov ntau ntawm cov lus teb qhia txog cov kab mob sib txawv ntawm cov neeg nyeem ntawv. Tsis tas li ntawd, tag nrho ntawm 23% ntawm cov neeg uas tau txais 80 milligrams ntawm Rezdiffra thiab 24% mus rau 28% ntawm cov neeg uas tau txais 100 milligrams ntawm Rezdiffra tau ntsib kev txhim kho hauv nplooj siab caws pliav thiab tsis muaj NASH zuj zus, piv rau 13% mus rau 15% ntawm cov neeg uas tau txais cov placebo, nyob ntawm txhua tus kws kho mob nyeem ntawv. Kev ua qauv qhia ntawm cov kev hloov pauv no hauv ib feem ntawm cov neeg mob tom qab tsuas yog ib xyoos ntawm kev kho mob yog qhov tseem ceeb, raws li cov kab mob feem ntau ua qeeb qeeb nrog cov neeg mob feem ntau siv xyoo lossis ntau xyoo los qhia txog kev loj hlob.
Cov teebmeem ntawm Rezdiffra
Cov kev mob tshwm sim feem ntau ntawm Rezdiffra suav nrog raws plab thiab xeev siab. Rezdiffra los nrog qee cov lus ceeb toom thiab kev ceev faj, xws li tshuaj tiv thaiv kab mob siab rau lub siab thiab cov kab mob gallbladder.
Kev siv Rezdiffra yuav tsum zam rau cov neeg mob uas muaj decompensated cirrhosis. Cov neeg mob yuav tsum tsis txhob siv Rezdiffra yog tias lawv tsim cov tsos mob lossis cov tsos mob ntawm qhov hnyav zuj zus nplooj siab ua haujlwm thaum nyob rau hauv kev kho mob Rezdiffra.
Cov tshuaj sib cuam tshuam ntawm Rezdiffra
Kev siv Rezdiffra tib lub sijhawm nrog qee yam tshuaj, tshwj xeeb tshaj yog statins rau txo cov roj cholesterol, tuaj yeem ua rau muaj kev cuam tshuam cov tshuaj tseem ceeb. Cov kws kho mob yuav tsum xa mus rau tag nrho cov ntaub ntawv sau tshuaj rau cov ntaub ntawv ntxiv ntawm cov tshuaj muaj feem cuam tshuam nrog Rezdiffra, pom zoo noj ntau npaum li cas thiab kev hloov pauv kev tswj hwm.
cov FDA Kev pom zoo Rezdiffra raws li txoj hauv kev pom zoo nrawm, uas tso cai rau kev pom zoo ua ntej ntawm cov tshuaj uas kho cov mob hnyav thiab hais txog qhov xav tau kev kho mob tsis txaus, raws li tus neeg sawv cev lossis tus kws kho mob nruab nrab qhov kawg uas tsim nyog yuav kwv yees txiaj ntsig kho mob. Qhov yuav tsum tau hais los saum toj no 54-hli kev kawm, uas tseem tab tom ua, yuav ntsuas cov txiaj ntsig kho mob tom qab 54 lub hlis ntawm kev kho Rezdiffra.
Rezdiffra tau txais Kev Kho Kom Zoo Tshaj Plaws, Txoj Kev Ceev Ceev thiab Kev Ntsuam Xyuas Qhov Tseem Ceeb rau qhov kev qhia no.
cov FDA tau tso cai pom zoo ntawm Rezdiffra rau Madrigal Pharmaceuticals.
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Tau qhov twg los:
FDA 2024. Xov Xwm Tshaj Tawm - FDA Pom Zoo Ua Ntej Kev Kho Mob rau Cov Neeg Mob Uas Cuam Tshuam Rau Cov Kab Mob Li Cas. Tshaj tawm 14 Lub Peb Hlis 2024. Muaj nyob ntawm https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-patients-liver-scarring-due-fatty-liver-disease
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 has been approved by the FDA of the USA for the treatment of adults with noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced liver scarring (fibrosis), to be used along with diet and exercise.){kind=link}