FDA Pom Zoo Rau Enspryng Rau Kab Mob Qhov Muag Thyroid, Kev Kho Mob Subcutaneous Thawj Zaug Hauv Tsev
Lub Koom Haum Saib Xyuas Khoom Noj thiab Tshuaj (FDA) ntawm Teb Chaws Asmeskas tau pom zoo rau Genentech's Enspryng (satralizumab-mwge) rau kev kho mob rau cov neeg laus uas muaj kab mob qhov muag thyroid (TED), lub tuam txhab tau tshaj tawm rau lub Kaum Hli 15 ntawm nws lub hauv paus chaw ua haujlwm hauv South San Francisco. Genentech, ib tug tswv cuab ntawm Roche Group, tau hais tias Enspryng yog thawj zaug thiab tsuas yog kev kho mob hauv tsev rau tus kab mob, thiab tus neeg mob lossis tus neeg saib xyuas tuaj yeem muab tshuaj tom qab kev cob qhia los ntawm tus kws kho mob.
Kab mob qhov muag thyroid, tseem hu ua Graves' ophthalmopathy, yog ib qho kev mob autoimmune ntawm lub qhov muag thiab cov nqaij nyob ib puag ncig. Cov tsos mob feem ntau suav nrog qhov muag bulging (proptosis), pom ob npaug, qhov muag retraction, liab, o thiab mob, thiab tus kab mob tuaj yeem hem qhov muag pom kev. Genentech hais tias TED cuam tshuam kwv yees li 155 ntawm txhua 100,000 tus neeg hauv Tebchaws Meskas thiab feem ntau tshwm sim rau cov neeg uas muaj hyperthyroidism.
Qhov kev pom zoo, uas tau txais tom qab kev tshuaj xyuas ua ntej, yog raws li ob txoj kev tshawb fawb Theem III, SatraGO-1 thiab SatraGO-2, uas tau sau npe tag nrho 258 tus neeg mob los ntawm 19 lub tebchaws. Hauv SatraGO-2, 52.9% ntawm cov neeg mob uas muaj TED nquag tau txais Enspryng tau ua tiav qhov kawg ntawm kev teb proptosis thaum lub lim tiam 24, piv rau 23.4% ntawm cov placebo, thiab 60.7% tau ua tiav qhov txo qis hauv kev pom ob npaug, piv rau 25.8% ntawm cov placebo. Tsis muaj cov cim qhia kev nyab xeeb tshiab tau txheeb xyuas. Genentech tau sau tseg tias SatraGO-1 tsis tau ua tiav nws qhov kawg ua tau zoo ua ntej, thiab tias kev pom zoo yog nyob ntawm tag nrho cov ntaub ntawv.
Qhov no yog qhov cim thib ob hauv Tebchaws Meskas rau Enspryng, tom qab nws tau pom zoo rau neuromyelitis optica spectrum disorder (NMOSD) xyoo 2020. Dr. César A. Briceño, tus kws tshawb nrhiav kev sim tshuaj thiab tus xibfwb qhia txog qhov muag ntawm Scheie Eye Institute ntawm University of Pennsylvania, tau hais tias kev xaiv subcutaneous tuaj yeem muab kev ywj pheej ntau dua rau cov neeg mob thiab cov kws kho mob thaum txo qhov hnyav ntawm kev kho mob raws li infusion. Dr. Levi Garraway, tus thawj coj kho mob ntawm Genentech, tau hais tias kev pom zoo muab kev xaiv tshiab tseem ceeb rau cov neeg uas muaj TED, uas tau ntsib kev xaiv kho mob tsawg ntev.
Qhov chaw: GSM · Tebchaws Meskas (Qhov kev tshaj tawm lus Askiv · Qhov kev tshaj tawm lus Suav qub)
Duab: 甲状腺眼病（格雷夫斯眼病）患者眼球突出与眼睑退缩临床照片（资料图）。照片：Jonathan Trobe 医学博士／密歇根大学 Kellogg 眼科中心，CC BY 3.0，经 Wikimedia Commons
- 2026-10-16FDA Pom Zoo Rau Enspryng Rau Kab Mob Qhov Muag Thyroid, Kev Kho Mob Subcutaneous Thawj Zaug Hauv TsevZaj dab neeg no
- 2026-10-17FDA Approves Enspryng for Thyroid Eye Disease, the First At-Home Subcutaneous Treatment for the Condition
