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

Thawj qhov kawg ntawm ob txoj kev tshawb fawb yog qhov feem pua ​​​​ntawm cov neeg mob uas tau mus txog tus neeg tshawb xyuas' qhov kev ntsuam xyuas tag nrho-kev kho mob tau zoo (IGA-TS) ntawm 8 lub lis piam ntawm kev kho mob-txhais tias yog qhov qhab nia IGA ntawm 0 (ua tiav daim tawv nqaij clearance) los yog 1 (yuav luag ua kom tiav daim tawv nqaij clearance), Thiab txhim kho yam tsawg kawg yog 2 ntsiab lus los ntawm theem pib. Cov ntsiab lus tseem ceeb thib ob suav nrog: qhov feem pua ​​​​ntawm cov neeg mob uas nws cheeb tsam eczema thiab qhov ntsuas qhov hnyav tau nce los ntawm ≥75% los ntawm theem pib (EASI75) ntawm 8 lub lis piam ntawm kev kho mob, thiab feem pua ​​​​ntawm cov neeg mob nrog kev txhim kho ntawm ≥4 cov ntsiab lus (NRS4) ntawm Pruritus Numerical Rating Scale ntawm 8th lub lim tiam ntawm kev kho mob Qhov feem ntawm cov neeg mob.

Ob qhov kev tshawb fawb tau ntsib cov ntsiab lus tseem ceeb thiab cov ntsiab lus tseem ceeb thib ob: Piv nrog rau kev kho mob (tsis yog tshuaj yeeb), 1.5% ntawm cov neeg mob hauv pab pawg kho mob Opzelura tau ntsib qhov teeb meem ntawm daim tawv nqaij tshem tawm thiab txo qhov khaus. Cov ntaub ntawv tshwj xeeb yog raws li nram no:

—— Hauv 8 lub lis piam ntawm kev kho mob, piv nrog cov pab pawg tsheb ([tsis yog tshuaj yeeb tshuaj]; TRuE AD1: 15.1%; TRuE AD2: 7.6%), 1.5% cream pawg (TRuE AD1: 53.8%; TRuE AD2) : 51.3%) Ib qho kev faib ua feem ntau ntawm cov neeg mob tau ua tiav kev kho mob IGA-TS (tag nrho cov txiaj ntsig p<>

—— Hauv lub lim tiam 8 ntawm kev kho mob, piv nrog cov pab pawg tsheb (TRuE AD1: 24.6%; TRuE AD2: 14.4%), 1.5% cream pab pawg (TRuE AD1: 62.1%; TRuE AD2: 61.8%) yog siab dua Tus nqi ntawm Cov neeg mob ua tiav EASI75 (qhov eczema cheeb tsam thiab qhov ntsuas qhov hnyav tau nce ≥75% los ntawm theem pib; ob qho tib si p-values ​​tsawg dua 0.0001).

—— Cov ntaub ntawv ntawm 2 cov kev tshawb fawb kuj qhia tau hais tias Opzelura cream kev kho mob muaj kev cuam tshuam sai, muaj txiaj ntsig thiab tsis tu ncua ntawm pruritus, uas yog qhov qhia txog kev ua neej zoo ntawm cov neeg mob atopic dermatitis. Nyob rau lub lim tiam thib 8 ntawm kev kho mob, piv nrog cov pab pawg tsheb (TRuE AD1: 15.4%; TRuE AD2: 16.3%), 1.5% cream pawg (TRuE AD1: 52.2%; TRuE AD2: 50.7%) muaj feem ntau ntawm Cov. Cov neeg mob ua tiav NRS4 (Kev txhim kho ntawm Pruritus Numerical Rating Scale qhab nia ≥ 4 cov ntsiab lus; feem: p< 0.0001,="">< 0.0001).="" kev="" txo="" qis="" hauv="" khaus="" sai="" tau="" pom="" nrog="" opzelura="" cream="" kho.="" piv="" nrog="" rau="" pab="" pawg="" tsheb,="" 1.5%="" cream="" pab="" pawg="" tau="" txo="" qis="" hauv="" itching="" numerical="" rating="" scale="" (nrs)="" hauv="" 12="" teev="" tom="" qab="" kev="" kho="" mob=""><>

—— Kev nyab xeeb tag nrho ntawm Opzelura cream hauv kev kho mob atopic dermatitis yog ua raws li cov ntaub ntawv tshawb fawb yav dhau los. Tag nrho cov xwm txheej thiab qhov hnyav ntawm cov xwm txheej tsis zoo (TEAE) hauv ob koob tshuaj pleev tshuaj kho mob thiab pab pawg neeg noj tshuaj thaum lub sij hawm 8 lub lis piam ntawm kev kho mob Qhov tshwm sim ntawm cov xwm txheej tsis zoo yog sib piv. Tsis muaj cov cim kev nyab xeeb tshiab tau pom.

Ruxolitinib cream yog Incyte' s patented formulation ntawm xaiv Janus kinase 1 thiab Janus kinase 2 (JAK1 / JAK2) inhibitorruxolitinib, tsim los rau kev siv tshuaj pleev ib ce. Ruxolitinib cream tau tsim los rau: (1) kho cov neeg mob me me mus rau nruab nrab atopic dermatitis (TRuE-AD project), (2) kho cov hluas thiab cov neeg laus nrog vitiligo (TRuE-V project). Incyte muaj txoj cai thoob ntiaj teb los tsim thiab ua lag luamruxolitinibcream.

Thaum Lub Kaum Hli 2019, Incyte tshaj tawm 52-lub lim tiam cov ntaub ntawv ntawm Phase II kawm ntawmruxolitinibcream nyob rau hauv kev kho mob ntawm vitiligo. Yav dhau los, txoj kev tshawb no tau mus txog qhov kawg ntawm qhov kawg: Tom qab 24 lub lis piam ntawm kev kho mob, piv nrog cov pab pawg tswj tsheb (tsis yog tshuaj yeeb tshuaj), ruxolitinib cream kho pab pawg muaj qhov feem ntau ntawm cov neeg mob ntawm lub ntsej muag vitiligo qhov ntsuas qhov hnyav dua li qhov kev txhim kho. ≥50% (F-VASI50). Cov txiaj ntsig zaum kawg ntawm lub lim tiam 52 tau pom tias qhov feem pua ​​​​ntawm cov neeg mob uas nws tag nrho vitiligo cheeb tsam qhov ntsuas qhov hnyav tau txhim kho los ntawm ≥50% los ntawm cov hauv paus (T-VASI50) tau soj ntsuam. Piv nrog rau kev tswj lub tsheb, ruxolitinib cream rejuvenated ntawm daim tawv nqaij cov kab mob ntawm cov kab mob vitiligo (Repigmentation) muaj kev txhim kho tseem ceeb, mus txog qhov tseem ceeb theem nrab ntawm txoj kev tshawb no. Tsis tas li ntawd, tom qab 52 lub lis piam ntawm kev kho mob nrogruxolitinibcream 1.5% ob zaug hauv ib hnub (BID), 58% ntawm cov neeg mob ua tiav F-VASI50, thiab 51% ntawm cov neeg mob tau txais kev txhim kho ntawm 75% (F-VASI75).

Ruxolitinib yog cov khoom siv tshuaj nquag ntawm Incyte' lub qhov ncauj tshuaj Jakafi. Cov tshuaj tau pom zoo rau 3 qhov kev qhia hauv Tebchaws Meskas: (1) Kev kho mob ntawm cov neeg laus cov neeg mob polycythemia (PV) uas muaj cov lus teb tsis txaus lossis tsis txaus siab rau sulfhydryluria; (2) Kev kho mob ntawm cov neeg laus nruab nrab thiab muaj kev pheej hmoo siab mob myelofibrosis (MF), suav nrog thawj MF, post-PV MF, post-tseem ceeb thrombocythemia MF; (3) Kev kho mob ntawm steroid-refractory acute graft-tiv thaiv-tus kab mob (GVHD) cov neeg mob. Ntawm lawv, qhov kev qhia thib peb tau pom zoo los ntawm FDA thaum lub Tsib Hlis 2019, thiab nws yog thawj cov tshuaj pom zoo rau kev kho mob ntawm qhov ntsuas no. Jakafi yog muag los ntawm Incyte hauv Tebchaws Meskas, thiab Novartis yog muag raws li Jakavi hom npe hauv khw sab nraum Tebchaws Meskas.

Tam sim no, Concert tseem tab tom tsim ibruxolitinibmolecule hloov nrog deuterium chemical technology-CTP-543. Hauv kev tshawb fawb theem II, nws tau pom tias muaj txiaj ntsig zoo hauv kev kho mob ntawm alopecia areata. Alopecia areata yog ib hom kab mob autoimmune uas ua rau cov plaub hau poob ib nrab los yog ua tiav. Kev hloov kho tshuaj deuterium ntawm ruxolitinib tuaj yeem hloov pauv nws cov tib neeg cov tshuaj pharmacokinetics, yog li txhim kho nws siv raws li kev kho mob rau alopecia areata. Hauv Tebchaws Meskas, FDA tau tso cai CTP-543 nrawm nrawm rau kev kho mob alopecia areata.