FDA xav kom JAK inhibitors ntxiv lub thawv dub ceeb toom ceeb toom txog kev pheej hmoo ntawm kev mob plawv hnyav

Tsis ntev los no, FDA tau tawm tswv yim thov JAK inhibitors uas tau pom zoo rau kev kho mob ntawm qee qhov mob hnyav ntxiv rau lub thawv dub ceeb toom tias" GG] quot; hauv daim ntawv lo. Cov ntaub ntawv no yog hloov kho tshiab ntawm FDA Tshuaj Kev Nyab Xeeb Kev Nyab Xeeb (DSC) tshaj tawm rau Lub Ob Hlis 4, 2021.

Raws li kev tshuaj xyuas tag nrho ntawm kev nyab xeeb ntawm kev sim tshuaj kho mob loj, Asmeskas FDA tau txiav txim siab tias kev siv tshuaj kho mob caj dab thiab mob plab ulcerative Xeljanz thiab Xeljanz XR (tofacitinib) ua rau muaj kev pheej hmoo loj ntawm cov teeb meem ntsig txog lub plawv, xws li lub plawv nres lossis mob hlab ntsha tawg, mob qog noj ntshav, ntshav txhaws thiab tuag. Qhov kev sim no piv Xeljanz nrog lwm cov tshuaj, qog necrosis factor (TNF) blocker, siv los kho mob rheumatoid mob caj dab. Cov txiaj ntsig kawg ntawm qhov kev sim kuj tseem pom tias qis koob tshuaj Xeljanz kuj tseem ua rau muaj kev pheej hmoo ntawm ntshav khov thiab tuag. Yav dhau los, tsab ntawv ceeb toom DSC raws li cov txiaj ntsig thaum ntxov ntawm qhov kev sim no tau hais tias ob lub tshuaj no tsuas yog ua rau muaj kev pheej hmoo ntawm cov ntshav txhaws thiab tuag thaum txhaj tshuaj ntau.

FDA xav kom ob qho tshuaj tiv thaiv kab mob tib yam li Xeljanz, uas yog Janus kinase (JAK) inhibitors, Olumiant (baritinib) thiab Rinvoq (upatinib) ntxiv nrog cov lus ceeb toom tshiab thiab hloov tshiab. Txij li Olumiant thiab Rinvoq tsis tau ua qhov kev kuaj mob loj txog kev nyab xeeb zoo ib yam li Xeljanz, lawv cov kev pheej hmoo tsis tau raug tshuaj xyuas tag nrho. Txawm li cas los xij, vim tias lawv muaj tib lub tswv yim ntawm kev ua Xeljanz, FDA ntseeg tias cov tshuaj no yuav muaj kev nyab xeeb zoo ib yam li Xeljanz.

Lwm qhov ob JAK inhibitors Jakafi (rucotinib) thiab Inrebic (fedratinib) tsis pom zoo rau kev kho mob caj dab thiab lwm yam kab mob ua paug, yog li tsis tas yuav hloov kho cov ntaub ntawv qhia tshuaj tib yam li Xeljanz, Xeljanz XR, Olumiant, thiab Rinvoq. Ob qhov tshuaj tau pom zoo rau kev kho cov kab mob ntawm cov ntshav, thiab FDA xav kom lawv hloov kho cov ntaub ntawv tshuaj sib txawv. FDA tau hais tias yog nws pom lwm cov ntaub ntawv kev nyab xeeb ntxiv lossis cov ntaub ntawv thiab xav tau hloov kho cov ntaub ntawv qhia tshuaj ntawm cov tshuaj no, lawv tuaj yeem nqis tes ua ntxiv thiab ceeb toom rau pej xeem.