US FDA pom zoo Opzelura cream: thawj cov tshuaj JAK inhibitor --- 1/2

Incyte tsis ntev los no tshaj tawm tias US Food and Drug Administration (FDA) tau pom zoo Opzelura (ruxolitinib) cream, uas yog cov tshuaj pleev xim JAK inhibitor rau lub sijhawm luv thiab tsis muaj kev kho mob ntev, thiab nws tsis tuaj yeem tswj tus mob zoo tom qab tau txais cov tshuaj pleev xim. Los yog thaum cov kev kho no tsis pom zoo, tsis muaj kev tiv thaiv kab mob me me mus rau nruab nrab atopic dermatitis (AD) cov tub ntxhais hluas (hnub nyoog ≥ 12 xyoos) thiab cov neeg laus.

Nws tsim nyog hais tias Opzelura yog thawj zaug thiab tsuas yog tshuaj pleev Janus kinase (JAK) inhibitor pom zoo los ntawm US FDA. Cov kev tshawb fawb tau pom tias txoj kev tsis zoo ntawm JAK-STAT txoj hauv kev ua rau cov yam ntxwv tseem ceeb ntawm AD, xws li khaus, khaus, thiab tawv nqaij tsis zoo. Hauv theem 3 kev tshawb fawb soj ntsuam, Opzelura kev kho mob txo cov tawv nqaij mob thiab khaus khaus cuam tshuam nrog AD. Thiab txo qhov khaus tuaj yeem txhim kho cov kab mob tseem ceeb thiab kev ua neej zoo rau cov neeg mob AD.

Atopic dermatitis (AD) yog ib qho mob ntev, tiv thaiv kab mob ntawm daim tawv nqaij uas cuam tshuam ntau dua 21 lab tus tib neeg hnub nyoog 12 xyoos thiab laus dua hauv Tebchaws Meskas. Nws yog yus muaj los ntawm o thiab khaus ntawm daim tawv nqaij. Ntau tus neeg mob tsis teb zoo rau cov kev kho mob uas twb muaj lawm. tswj. Cov neeg mob AD kuj tseem raug rau cov kab mob, kab mob thiab cov kab mob fungal. Kev pom zoo ntawm Opzelura cream yuav muab cov neeg mob nrog ib qho tseem ceeb uas tsis yog-steroidal, anti-inflammatory, tshuaj pleev ib ce.

ruxolitinibcream tau tsim los kho: (1) me me mus rau nruab nrab atopic dermatitis (TRuE-AD project); (2) cov tub ntxhais hluas thiab cov neeg laus vitiligo (TRuE-V project). Hais txog kev kho mob ntawm vitiligo, cov ntaub ntawv luam tawm yav dhau los qhia tau hais tias piv nrog kev tswj hwm lub tsheb (cov tshuaj tsis muaj tshuaj), cov neeg mob hauv lubruxolitinibCov pab pawg neeg kho mob tau zoo txhim kho lub ntsej muag vitiligo qhov hnyav Performance index cov qhab nia, thiab cov tawv nqaij ntawm cov kab mob vitiligo (repigmentation) muaj kev txhim kho tseem ceeb.

TRuE-AD project data

FDA pom zoo Opzelura raws li cov ntaub ntawv los ntawm TRuE-AD qhov project. Txoj haujlwm no suav nrog ob qho kev sib tw, kev tswj xyuas tsheb, theem tseem ceeb 3 kev tshawb fawb TRuE-AD2 (NCT03745651) thiab TRuE-AD1 (NCT03745638) nrog tib tus qauv tsim. Tag nrho ntawm 1250 tus neeg mob tau cuv npe, thiab Opzelura cream raug tshuaj xyuas 2 zaug hauv ib hnub. Kev nyab xeeb thiab kev ua tau zoo ntawm BID hauv kev kho cov tub ntxhais hluas thiab cov neeg laus (hnub nyoog ≥ 12 xyoos) nrog mob me rau mob atopic dermatitis (AD).