Deucravacitinib nkag mus rau Kev Ntsuam Xyuas hauv Tebchaws Meskas, Nyiv thiab Europe: Cov nyhuv Curative Defeats Amgen Otezla!

Bristol-Myers Squibb (BMS) tsis ntev los no tau tshaj tawm tias US Food and Drug Administration (FDA) thiab European Medicines Agency (EMA) tau txais raws li Daim Ntawv Thov Tshuaj Tshiab (NDA) thiab Kev Tso Cai Ua Lag Luam (MAA) ntawm cov tshuaj tiv thaiv kab mob. TYK2 inhibitor deucravacitinib. ): Rau kev kho mob ntawm cov neeg laus cov neeg laus uas muaj nruab nrab mus rau hnyav plaque psoriasis (PsO). FDA tau teeb tsa NDA' s" Tsab Cai Tshuaj Siv Tshuaj Siv Tshuaj (PDUFA)" Lub hom phiaj hnub rau lub Cuaj Hlis 10, 2022. Tsis tas li ntawd, Ministry of Health, Labor thiab Welfare (MHLW) ntawm Nyiv kuj tau txais deucravacitinib rau kev kho cov neeg laus uas muaj mob hnyav rau cov quav hniav psoriasis, pustular psoriasis, thiab erythroderma-type psoriasis.

Deucravacitinib yog thawj-hauv-chav kawm, qhov ncauj, xaiv tyrosine kinase 2 (TYK2) inhibitor nrog cov txheej txheem tshwj xeeb ntawm inhibiting IL-12, IL-23, thiab hom 1 interferon pathways. Cov tshuaj yog thawj TYK2 inhibitor los soj ntsuam hauv kev tshawb fawb soj ntsuam rau kev kho mob ntawm ntau yam kab mob tiv thaiv kab mob.

Deucravacitinib tshuaj qauv

Kev tswj hwm kev thov ntawm deucravacitinib yog ua raws cov txiaj ntsig zoo ntawm ob theem tseem ceeb 3 kev sim tshuaj (POETYK PSO-1, POETYK PSO-2). Ob qhov kev sim no tau ua nyob rau hauv cov neeg laus cov neeg laus uas muaj mob hnyav rau cov plaque psoriasis thiab piv rau deucravacitinib (6 mg ntawm qhov ncauj ib hnub ib zaug) nrog cov placebo thiab Otezla (apremilast, 30 mg, ob zaug ib hnub).

Cov txiaj ntsig tau pom tias ob qhov kev sim no tau mus txog qhov kawg ntawm qhov tseem ceeb thiab theem nrab: piv nrog cov placebo thiab Otezla, deucavacitinib tau pom kev txhim kho tseem ceeb hauv kev kho mob ntawm daim tawv nqaij tshem tawm, cov tsos mob hnyav, thiab kev ua neej zoo, suav nrog hauv 16th piv nrog cov placebo thiab Otezla, ib qho kev faib ua feem ntau ntawm cov neeg mob tau ua tiav thaj tsam psoriasis thiab qhov ntsuas qhov hnyav ntawm qhov kev txhim kho tsawg kawg yog 75% los ntawm lub hauv paus (PASI75), thiab tus kws kho mob zoo li qub kev ntsuas tag nrho (sPGA) qhab nia tau meej meej lossis yuav luag tiav. Cleared (sPGA 0/1), piv nrog Otezla nyob rau hauv lub 24th lub lim tiam, ib tug ntau dua kev faib ua feem ntawm cov neeg mob mus txog PASI75 thiab sPGA 0/1 thiab tuav mus txog rau 52nd lub lim tiam. Hauv txoj kev tshawb no, deucravacitinib muaj kev nyab xeeb thiab ua tau zoo, nrog tus nqi qis ntawm kev txiav tawm los ntawm cov xwm txheej tsis zoo, thiab tsis muaj qhov chaw kuaj mob loj heev. .

Jonathan Sadeh, Tus Lwm Thawj Coj ntawm Immunology thiab Fibrosis Development ntawm Bristol-Myers Squibb, tau hais tias: "Rau cov neeg mob uas muaj mob hnyav rau cov quav hniav psoriasis, muaj qhov xav tau sai rau kev kho qhov ncauj kom zoo dua qub, vim tias ntau tus neeg mob tseem tsis tau txais Kev kho mob txaus, lossis txawm tias tsis muaj kev kho mob. Cov txiaj ntsig ntawm ob theem tseem ceeb 3 kev sim POETYK-PSO qhia tias deucravacitinib muaj peev xwm txhim kho tus qauv ntawm kev saib xyuas qhov ncauj rau cov pab pawg neeg mob tsim nyog rau kev kho mob. Peb tos ntsoov yuav txuas ntxiv koom tes nrog FDA thiab EMA coj deucravacitinib sai li sai tau rau cov neeg mob thiab kws kho mob."