Tebchaws Asmeskas FDA Tau Txais Takeda Qhov Ncauj Orexin Receptor Agonist TAK-994 Kev Kho Tus Kheej Kev Tsim Kho (BTD)!

Takeda Pharmaceuticals (Takeda) tsis ntev los no tshaj tawm tias Asmeskas Cov Khoom Noj thiab Tshuaj Yeeb Tshuaj (FDA) tau tso cai TAK-994 Kev Kho Tus Kheej Tsim Kho (BTD), qhov ncauj orexin agonist nyob rau theem 2 qhov chaw kho mob, tsom mus rau lub hom phiaj xaiv orexin-2 receptor.

Tam sim no, TAK-994 tab tom raug tsim los kho ntau dhau ntawm kev tsaug zog thaum nruab hnub (EDS) hauv cov neeg mob uas muaj narcolepsy yam 1 (NT1). Nov yog kab mob paj hlwb ntev uas hloov pauv lub sijhawm pw tsaug zog. EDS yog cov tsos mob tseem ceeb ntawm NT1, uas yog tus neeg' tsis muaj peev xwm ua kom tsaug zog thiab ceeb toom txhua hnub, thiab tsaug zog yam tsis xav tau lossis lub sijhawm tsis tsim nyog txhua hnub.

BTD yog ib txoj kev tshuaj xyuas tshuaj tshiab ntawm FDA, uas muaj lub hom phiaj txhawm rau txhawm rau txhim kho thiab tshuaj xyuas cov tshuaj tshiab rau kev kho mob hnyav lossis muaj kev phom sij rau lub neej, thiab muaj cov ntaub ntawv pov thawj ua ntej sib piv nrog cov tshuaj kho mob tam sim no, cov tshuaj tshiab uas tuaj yeem ua tau muaj peev xwm txhim kho qhov xwm txheej ntawm tus kab mob. BTD-tau txais cov tshuaj tuaj yeem tau txais cov lus qhia ze rau suav nrog cov kws lis haujlwm laus hauv FDA thaum tshawb fawb thiab kev txhim kho, thiab tsim nyog rau kev tshuaj xyuas thiab muaj peev xwm tshuaj xyuas thawj zaug thaum tshuaj xyuas kom ntseeg tau tias cov neeg mob tau txais kev kho mob tshiab hauv lub sijhawm luv tshaj.

Raws li cov ntaub ntawv tshaj tawm los ntawm Lub Chaw rau Kev Tshuaj Xyuas Tshuaj (CDE) ntawm National Medical Products Administration (NMPA), TAK-994 tau txais ntawv tso cai pom zoo rau kev kuaj mob hauv Suav teb thaum Lub Xya Hli 2020.

TAK-994 tau tshawb pom los ntawm Takeda' chaw kuaj mob hauv Shonan, Nyij Pooj. Nws yog ib feem ntawm Qhib Kev Tsim Kho Tshiab ntawm Shonan Health Innovation Park thiab yog cov khoom lag luam tseem ceeb rau Takeda' s pioneering multi-cuab tam orexin-tsom franchise. Qhov BTD no yog lub cim tseem ceeb hauv Takeda' kev txhim kho kev txhim kho kom coj tau qhov kev kho tseem ceeb no rau cov neeg mob NT1.

FDA tau tso cai TAK-994 BTD, ib nrab raws cov ntaub ntawv kho mob thaum ntxov thiab ua ntej. Cov ntaub ntawv no qhia tias hauv NT1 cov neeg mob, TAK-994 tuaj yeem txhim kho lub hom phiaj thiab qhov ntsuas qhov ntsuas tau ntawm kev sawv nruab hnub. Tam sim no, TAK-994 tab tom kawm theem 2 (TAK-994-1501). Cov ntaub ntawv los ntawm kev kawm tiav Phase 2 yuav tshaj tawm ntawm lub rooj sib tham tshawb fawb yav tom ntej tom qab qhov kev kawm tiav tiav.

Sarah Sheikh, lub taub hau ntawm Takeda' thaj chaw kho kab mob paj hlwb, tau hais tias: "Cov neeg mob uas muaj tus mob narcolepsy yam 1 muaj kev tsaug zog thaum nruab hnub ntau dhau, uas txhais tau tias lawv feem ntau tsaug zog tom haujlwm lossis tom tsev kawm ntawv. Yog pom zoo, TAK-994 muaj peev xwm hloov peb txoj kev kho tam sim no ntawm NT1. Txoj hauv kev los daws teeb meem ntawm sab hauv orexin tsis txaus ntawm qhov tseem ceeb ntawm tus kab mob. Orexin ua lub luag haujlwm tseem ceeb hauv kev tswj kev pw tsaug zog-sawv ntawm tib neeg lub cev, thiab txhawb txoj hauv kev hauv lub hlwb uas txhawb nqa lub cev'"