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 muaj mob siab steatohepatitis uas tsis yog cirrhotic thiab tsis yog cawv (NASH) uas kuj muaj qhov txhab ntawm daim siab tseem tsis tau muaj tshuaj uas tuaj yeem kho lawv lub siab puas tsuaj ncaj qha . FDA pom zoo rau Rezdiffra, thawj zaug, yuav muab kev xaiv kho rau cov neeg mob no, ntxiv rau kev noj zaub mov thiab kev tawm dag zog.
NASH yog qhov tshwm sim ntawm kev nce qib ntawm cov kab mob rog hauv siab uas tsis yog los ntawm kev haus dej cawv uas qhov kev o ntawm lub siab , dhau sijhawm, tuaj yeem ua rau daim siab caws pliav thiab ua haujlwm tsis zoo ntawm daim siab. 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 Tebchaws Meskas muaj NASH nrog qhov nruab nrab mus rau qib siab caws pliav, nrog rau tus lej ntawd xav tias 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 raug soj ntsuam raws li kev tshuaj xyuas ntawm qhov kawg ntawm tus neeg sawv cev thaum lub hlis 12 hauv kev sim tshuaj 54-hli, randomized, ob chav dig muag placebo-tswj. Qhov kawg ntawm tus neeg sawv cev ntsuas qhov dav ntawm kev mob siab thiab caws pliav. Tus neeg txhawb nqa yuav tsum tau ua 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 qho kev tshawb fawb 54-hli, uas tseem tab tom ua. Txhawm rau sau npe rau hauv kev sim tshuaj, cov neeg mob yuav tsum tau kuaj lub siab qhia txog kev mob vim NASH nrog rau qhov caws pliav siab nruab nrab lossis siab heev . Hauv kev sim tshuaj, 888 tus neeg tau raug xaiv los ntawm random kom tau txais ib qho ntawm cov hauv qab no: placebo (294 tus neeg); 80 milligrams ntawm Rezdiffra (298 tus neeg); lossis 100 milligrams ntawm Rezdiffra (296 tus neeg); ib zaug ib hnub, ntxiv rau kev saib xyuas tus qauv rau NASH, uas suav nrog kev qhia rau kev noj zaub mov zoo thiab kev tawm dag zog.
Thaum 12 lub hlis, kev kuaj mob siab qhia tau tias feem ntau ntawm cov neeg mob uas tau kho nrog Rezdiffra tau daws teeb meem NASH lossis kev txhim kho ntawm daim siab caws pliav piv rau cov neeg uas tau txais placebo. Tag nrho ntawm 26% txog 27% ntawm cov neeg mob uas tau txais 80 milligrams ntawm Rezdiffra thiab 24% txog 36% ntawm cov neeg mob uas tau txais 100 milligrams ntawm Rezdiffra tau daws teeb meem NASH thiab tsis muaj kev mob siab zuj zus, piv rau 9% txog 13% ntawm cov neeg uas tau txais placebo thiab kev qhia txog kev noj zaub mov thiab kev tawm dag zog. Cov lus teb ntawm cov kws kho mob sib txawv. Tsis tas li ntawd, tag nrho ntawm 23% ntawm cov neeg mob uas tau txais 80 milligrams ntawm Rezdiffra thiab 24% txog 28% ntawm cov neeg mob uas tau txais 100 milligrams ntawm Rezdiffra tau ntsib kev txhim kho ntawm daim siab caws pliav thiab tsis muaj kev mob siab zuj zus ntawm NASH, piv rau 13% txog 15% ntawm cov neeg uas tau txais placebo, nyob ntawm txhua tus kws kho mob cov lus teb. Qhov pom tseeb ntawm cov kev hloov pauv no hauv ib feem ntawm cov neeg mob tom qab ib xyoos ntawm kev kho mob yog qhov tseem ceeb, vim tias tus kab mob feem ntau qeeb zuj zus nrog rau feem ntau cov neeg mob siv sijhawm ntau xyoo lossis txawm tias kaum xyoo los qhia txog kev nce qib.
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.
Yuav tsum tsis txhob siv Rezdiffra rau cov neeg mob uas muaj kab mob cirrhosis uas tsis zoo. Cov neeg mob yuav tsum tsis txhob siv Rezdiffra yog tias lawv muaj cov cim lossis tsos mob ntawm kev ua haujlwm ntawm lub siab thaum noj 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.
FDA tau pom zoo rau Rezdiffra raws li txoj kev pom zoo sai dua, uas tso cai rau kev pom zoo ua ntej cov tshuaj uas kho cov mob hnyav thiab daws qhov xav tau kev kho mob uas tsis tau raws li qhov xav tau, raws li qhov kawg ntawm kev kho mob hloov chaw lossis nruab nrab uas yuav kwv yees tau qhov txiaj ntsig ntawm kev kho mob. Kev tshawb fawb 54-lub hlis uas yuav tsum tau ua, uas tseem tab tom ua, yuav ntsuas qhov txiaj ntsig ntawm kev kho mob tom qab 54 lub hlis ntawm kev kho mob 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.
FDA tau tso cai rau Madrigal Pharmaceuticals kom pom zoo rau Rezdiffra.
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Tau qhov twg los:
FDA 2024. Xov xwm tshaj tawm - FDA Pom Zoo Thawj Txoj Kev Kho Mob Rau Cov Neeg Mob Uas Muaj Kab Mob Siab Vim Muaj Kab Mob Siab Rog. Tshaj tawm rau hnub tim 14 Lub Peb Hlis 2024. Muaj nyob rau 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}