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Otsuka Pharmaceutical Deltyba (Dilamani) 25mg Dispersible Tablets Pom zoo hauv EU

[Nov 28, 2021]


Otsuka Pharma tsis ntev los no tshaj tawm tias European Commission (EC) tau pom zoo Deltyba (delamanid) 25mg dispersible ntsiav tshuaj formulations. Thaum txoj kev npaj kho mob tsis tuaj yeem tsim tau, qhov kev npaj Deltyba no tuaj yeem siv los ua ib feem ntawm txoj kev npaj kho mob rau kev kho cov menyuam yaus uas muaj kab mob ntsws ntau yam tshuaj tiv thaiv kab mob ntsws (MDR-TB) hnyav ≥10kg.


Lub" Daim Ntawv Qhia Ntiaj Teb Tuberculosis 2020" muab tso ua ke los ntawm Lub Koom Haum Saib Xyuas Kev Noj Qab Haus Huv Hauv Ntiaj Teb tau taw qhia tias 1.2 lab tus menyuam yaus (0 mus rau 14 xyoo) raug kev txom nyem los ntawm tuberculosis (TB) xyoo 2019. Tsis tas li ntawd, raws li ib daim ntawv luam tawm nyob rau hauv International Journal of Tuberculosis thiab mob ntsws, 25,000 txog 32,000 tus menyuam yaus. thoob ntiaj teb tau txais kev tiv thaiv kab mob ntau yam tshuaj tiv thaiv kab mob (MDR-TB) txhua xyoo, thiab kwv yees li 22% ntawm cov menyuam yaus uas muaj MDR-TB tuaj yeem tuag. Ib lub hom phiaj tshiab thoob ntiaj teb tau teeb tsa los ntawm 2018 UN General Assembly High-Level Lub Rooj Sib Tham ntawm Tuberculosis yog kho 115,000 tus menyuam yaus uas muaj tshuaj tiv thaiv TB hauv 5 xyoos.


Masanori Kawasaki, Tus Thawj Coj ntawm Otsuka Pharmaceutical's Ntiaj Teb Tuberculosis Project, tau hais tias: "Otsuka Pharmaceutical tau tshawb fawb thiab txhim kho tuberculosis tau ntau xyoo, nrog lub hom phiaj ntawm kev muab kev kho mob rau cov neeg mob ntau li ntau tau thiab thaum kawg tshem tawm cov kab mob thoob ntiaj teb. Peb cia siab rau qhov kev pom zoo tshiab. Daim ntawv Deltyba ntau npaum li cas yuav pab tau cov me nyuam uas kho MDR-TB. Peb yuav txuas ntxiv mus ua kom tiav Lub Hom Phiaj Kev Txhim Kho Kom Zoo los ntawm kev tsim cov tshuaj tiv thaiv kab mob."

delamanid

delamanid cov qauv tshuaj


Tuberculosis (TB) yog kab mob kis los ntawm Mycobacterium tuberculosis (Mycobacterium tuberculosis), uas feem ntau cuam tshuam rau lub ntsws. Multidrug-resistant tuberculosis hais txog tuberculosis uas tiv taus yam tsawg kawg yog isoniazid thiab rifampicin. Ob cov tshuaj no yog ob lub ntsiab tshuaj tiv thaiv kab mob uas siv rau hauv cov txheej txheem kho tuberculosis.


Deltyba yog cov tshuaj tua kab mob uas tsim los ntawm Otsuka Pharmaceutical. Nws muaj cov txheej txheem tshiab ntawm kev tiv thaiv tuberculosis thiab tuaj yeem cuam tshuam cov metabolism ntawm Mycobacterium tuberculosis (MTB) cell phab ntsa. Deltyba ua haujlwm los ntawm inhibiting cov synthesis ntawm mycolic acid, uas yog ib feem ntawm lub cell phab ntsa ntawm Mycobacterium tuberculosis (MTB). Deltyba muaj cov kab mob bactericidal siab tawm tsam ntau yam kab mob MTB hauv vitro, suav nrog cov kab mob uas tiv taus cov tshuaj tiv thaiv kab mob thawj zaug (xws li isoniazid thiab rifampicin).


Tam sim no, Deltyba tau pom zoo hauv Tebchaws Europe, Nyiv, Kaus Lim Qab Teb, Tuam Tshoj, Is Nrias teb, South Africa, Russia thiab lwm lub tebchaws. Cov tshuaj tau ntxiv rau WHO Tus Qauv Sau Cov Tshuaj Tseem Ceeb hauv xyoo 2015 thiab tau siv los kho cov neeg mob uas muaj ntau yam tshuaj tiv thaiv kab mob (MDR-TB) hauv ntau dua 110 lub tebchaws. Xyoo tas los hauv Tebchaws Europe, Deltyba 50mg zaj duab xis-coated ntsiav tshuaj tau pom zoo siv rau cov menyuam yaus thiab cov tub ntxhais hluas uas hnyav li 30kg.