FDA Pom Zoo Rhapsido Ua Kev Kho Mob Thawj Zaug Rau Cov tsos mob Dermographism
Novartis tshaj tawm hauv East Hanover, New Jersey, thaum Lub Kaum Hli 7 tias Lub Chaw Saib Xyuas Khoom Noj thiab Tshuaj ntawm Tebchaws Meskas tau pom zoo Rhapsido (remibrutinib) ua thawj txoj kev kho mob rau cov neeg laus uas muaj cov tsos mob dermographism (SD) uas tus kab mob tsis raug tswj hwm los ntawm H1 antihistamines.
Cov tsos mob dermographism yog hom mob urticaria uas tshwm sim ntau tshaj plaws: kev sib txhuam ntawm daim tawv nqaij txhua hnub, khawb lossis sib txhuam ua rau mob pob khaus thiab khaus. Ntau tshaj 50 feem pua ntawm cov neeg mob tseem muaj tsos mob txawm tias noj cov tshuaj H1 antihistamines. Rhapsido yog ib qho tshuaj noj, xaiv tau zoo Bruton's tyrosine kinase (BTK) inhibitor uas thaiv txoj hauv kev uas cuam tshuam nrog kev tso tawm histamine, uas yog tus tsav tsheb tseem ceeb ntawm mob pob khaus thiab o. Nws yog noj ua 25 mg ntsiav tshuaj ob zaug ib hnub.
Qhov kev pom zoo yog raws li SD cohort ntawm Theem III RemIND kev sim, uas tau sau npe 115 tus neeg laus uas tseem muaj tsos mob ntawm cov tshuaj antihistamines H1 tiam thib ob. Thaum Lub Limtiam 12, 29.3 feem pua ntawm cov neeg mob kho nrog Rhapsido tau daws qhov mob pob khaus tag nrho piv rau 14.0 feem pua ntawm cov neeg mob placebo (p = 0.0229), nrog rau cov lus teb pom thaum ntxov li Lub Limtiam 2. Novartis tau hais tias cov ntaub ntawv kev nyab xeeb hauv SD yog sib xws nrog nws cov kev paub hauv kev mob urticaria spontaneous, tsis tas yuav tsum tau saib xyuas hauv chaw kuaj mob.
Rhapsido tau pom zoo thawj zaug thaum lub Cuaj Hli 2025 rau kev kho mob urticaria spontaneous (CSU) thiab tam sim no yog tib qho kev kho mob uas tau pom zoo hauv Tebchaws Meskas rau ob hom mob hives ntev tshaj plaws. "Kev pom zoo hnub no yog ib qho tseem ceeb rau cov neeg uas muaj SD," Victor Bultó, Thawj Tswj Hwm, Tebchaws Meskas, ntawm Novartis tau hais.
[txuas: https://www.novartis.com/us-en/news/media-releases/novartis-rhapsido-remibrutinib-receives-fda-approval-first-treatment-symptomatic-dermographism-sd-expanding-its-use-beyond-chronic-spontaneous-urticaria-csu|Novartis tshaj tawm xov xwm]
Qhov chaw: GSM · Tebchaws Meskas (Qhov kev tshaj tawm lus Askiv · Qhov kev tshaj tawm lus Suav qub)
Duab: 皮肤划痕性荨麻疹的风团（资料图）。JAguayo18 摄，CC BY-SA 4.0，经 Wikimedia Commons。 / Wheals of symptomatic dermographism (file photo). Photo by JAguayo18, CC BY-SA 4.0, via Wikimedia Commons.
