AbbVie Oriahnn Pom Zoo Txog Kev Coj khaub Ncaws Pob Ntseg Nrog Rau Kev Txiav Txim Rau Menyuam

AbbVie thiab Neurocrine Biosciences tsis ntev los no tshaj tawm tias Tsoom Fwv Meskas FDA tau pom zoo Oriahnn (elagolix, estradiol, norethindrone acetate tsiav tshuaj; elagolix tsiav tshuaj) yog thawj qhov tsis phais qhov ncauj tshuaj rau kev kho mob premenopausal poj niam thiab uterine leeg coob ntawm cev ntas los ntshav uas cuam tshuam nrog lub qog, lub sijhawm ua haujlwm rau kev kho mob tuaj yeem txog 24 hli.

Uterine fibroids, tseem hu ua leiomyomas lossis fibroids, yog estrogen thiab progestin-nyob rau lub tsev menyuam tsis mob qog, uas tsis yog-qog ua rau cov qog ua kom cov leeg mob ua qog. Fibroids yog hom kev loj hlob txawv tshaj plaws hauv tus poj niam lub plab mog thiab qhov ntau ntawm cov hlav qog nqaij hlav hauv cov poj niam ntawm lub hnub nyoog yug menyuam. Lawv tuaj yeem cuam tshuam 70% ntawm cov poj niam dawb tshaj hnub nyoog 50 thiab 80% ntawm cov poj niam African-Asmeskas hauv Tebchaws Meskas. Qhov loj me, cov duab, naj npawb thiab qhov chaw ntawm cov fibroids tuaj yeem hloov thaum loj hlob thiab tuaj yeem ua asymptomatic, tab sis qee tus poj niam nws tuaj yeem ua rau cov tsos mob xws li los ntshav. Kev lig kev cai, uterine fibroids feem ntau yog kho los ntawm kev phais mob (hysterectomy, hysteromyomectomy), uas yog lub hauv paus tseem ceeb rau hysterectomy hauv Tebchaws Meskas. Lwm yam kev kho mob suav nrog endometrial ablation, uterine artery embolization, magnetic resonance imaging-guided focused ultrasound, thiab kev kho tshuaj xws li tshuaj tiv thaiv qhov ncauj, progestins, xaiv progesterone receptor modulators, thiab gonadotropin-tso cov tshuaj hormones (GnRH) agonists thiab antagonists.

Kev pom zoo yog ua raws li cov txiaj ntsig ntawm ob qho kev xaiv ib qho, ob lub qhov muag dig muag, cov tshuaj placebo-tswj theem 3 kev soj ntsuam ntawm ELARIS UF-I thiab ELARIS UF-II rau kev ntsuas ntawm uterine fibroids. Ob qhov kev tshawb fawb zoo ib yam yog tsim los soj ntsuam elagolix ob zaug ib hnub 300 mg ua ke nrog cov tshuaj" kev kho ntxiv" (estradiol 1 mg thiab norethindrone acetate 0.5 mg ib hnub ib zaug; los hloov cov tshuaj endogenous nrog kev txo qis) hauv cov poj niam nrog ntshav tawm los ntshav-fibroids. Kev sib hais tau teeb tsa cov pab pawg elagolix ib leeg (300 mg ob zaug ib hnub) los tshuaj xyuas cov txiaj ntsig ntawm kev sib xyaw ua ke hloov kho ntawm cov kev tshuaj ntsuam-txo qis ntawm cov tshuaj elagolix. Ob txoj kev tshawb nrhiav muaj ze li ntawm 800 tus poj niam muaj hnub nyoog coj los ntshav ntau (los ntshav coj los ntshav) muaj feem cuam nrog uterine fibroids nyob thaj tsam li 100 chaw kho mob hauv Tebchaws Meskas thiab Canada. Lub hauv paus ntsiab lus tseem ceeb nyob rau lub hli dhau los ntawm kev kho mob, ntsuas los ntawm txoj kev kho mob heme, elagolix monotherapy lossis elagolix ua ke nrog kev kho tshuaj hormone piv nrog cov placebo, tus neeg mob' s lub cev ntas ntshav tsawg dua 80 ml, thiab los ntawm lub hauv paus rau lub hlis tas los ntshav coj khaub ncaws txo tsawg tsawg 50%.

Tag nrho ntawm 412 tus poj niam hauv UF-1 mus sib hais thiab 378 tus poj niam hauv UF-2 mus sib hais tau muaj kev xaiv thiab tau txais kev kho mob elagolix lossis cov tshuaj placebo. Cov txiaj ntsig tau pom tias hauv ob qho kev sim ntawm elagolix ua ke nrog kev hloov kho tshuaj hormones, 68.5% ntawm cov neeg mob UF-1 mus txog qhov kawg thaum pib thiab 76.5% ntawm UF-2 tau mus txog qhov kawg; hauv cov pab pawg tau txais kev kho mob monagolix xwb, UF-1 Qhov feem ntawm cov neeg mob uas ua tau raws li cov ntsiab lus xaus hauv UF-2 thiab 8UF yog 84.1% thiab 77%, feem, thaum cov feem ntawm cov neeg mob uas tau ntsib cov ntsiab lus kawg hauv cov pawg placebo. 8.7% thiab 10%, feem (P< 0.001).="" piv="" nrog="" cov="" tshuaj="" placebo,="" elagolix="" ua="" ke="" nrog="" kev="" kho="" tshuaj="" hormones="" ntau="" dua="" ua="" rau="" kub="" kub="" (hauv="" uf-1="" thiab="" uf-2)="" thiab="" uterine="" los="" ntshav="" (hauv="" uf-1).="" tab="" sis="" kev="" kho="" hormonal="" tsis="" muaj="" zog="" cov="" tshuaj="" estrogen="" tsawg="" ntawm="" elagolix,="" tshwj="" xeeb="" los="" txo="" qis="" nws="" cov="" pob="" txha="" ntawm="" pob="">

Cov kws tshawb nrhiav tau luam tawm cov ntaub ntawv los ntawm ob txoj kev tshawb fawb nyob rau hauv New England Journal of Medicine thiab tau hais tias Oriahnn tau mus txog qhov chaw kho mob tseem ceeb kawg ntawm kev txo qis los ntshav. Kwv yees li 70 feem pua ​​ntawm cov poj niam tsis tau los ntshav kev coj khaub ncaws, piv nrog tsuas yog 10% hauv cov pawg placebo (ob qho kev sim P tsawg dua 0.001). Oriahnnn tseem txo qis ntshav los ntshav los ntawm uterine fibroids los ntawm 50% hauv thawj lub hlis tom qab siv.

Tab sis Oriahnn kuj muaj qee cov kev mob tshwm sim. Ob lub tuam txhab tau taw qhia hauv kev tshaj tawm tias cov tshuaj yuav ua rau muaj kev pheej hmoo mob plawv, mob ntshav lossis ntshav khov hauv cov neeg mob, tshwj xeeb tshaj yog cov neeg laus dua 35 xyoo, haus luam yeeb thiab muaj keeb kwm mob ntshav siab. Ntxiv rau, vim qhov pheej hmoo ntawm cov pob txha tsis zoo thiab tsis muaj peev xwm hloov tau, kev siv Oriahnn yuav tsum tau txwv txog 24 lub hlis.

Oriahnn yog cov tshuaj noj qhov ncauj tsim ntawm elagolix thiab E2 / NETA (estradiol / norethindrone acetate), uas pab cov neeg mob txo qhov txo qis los ntshav ntau ntau thiab tsim cov tshuaj muaj feem cuam tshuam nrog estrogen. Ntawm lawv, elagolix yog qhov ncauj, me me molecule GnRH receptor antagonist, los ntawm inhibiting pituitary gonadotropin-tso cov tshuaj hormones receptor, thiab thaum kawg txo cov qib ntawm circulating gonadotropin.

Elagolix (lub npe lag luam Orilissa) tseem yog cov tshuaj sib koom tsim los ntawm AbbVie thiab Neurocrine Biosciences. Nws yog siv rau hauv cov poj niam cov poj niam mob menorrhagia txuam nrog uterine fibroids thiab mob me mus rau mob hnyav cuam tshuam nrog endometriosis.