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Johnson&Johnson Johnson Uptravi cov leeg npaj tau thov rau npe hauv Tebchaws Meskas

[Oct 16, 2020]

Janssen Cov Chaw Ua Tshuaj, ib lub chaw tsim khoom ntawm Johnson& Johnson (JNJ), tsis ntev los no tau tshaj tawm tias nws tau xa Daim Ntawv Thov Kev Tshuaj Yeeb Tshuaj Tshiab (NDA) rau Uptravi (selexipag) tso ntshav (IV) mus rau Asmeskas Chaw Tswj Khoom Noj thiab Tshuaj (FDA) rau kev kho mob tam sim no tau siv tshuaj kho qhov ncauj tab sis tsis muaj ib ntus rau cov neeg laus cov neeg mob uas mob ntsws (PAH, WHO pab pawg I) tau txais kev kho mob qhov ncauj thiab WHO kev faib qib II-III. Hauv PAH cov neeg mob, vim tias kev hloov zuj zus ntawm tus kab mob, kev cuam tshuam ntawm kev kho yuav tsum zam.


Uptravi yog tus xaiv prostacyclin IP receptor agonist. Hauv xyoo 2015, FDA tau pom zoo rau qhov ncauj Uptravi los kho PAH kom ncua kev muaj mob thiab txo qis kev pheej hmoo pw hauv tsev kho mob.

selexipag

Selexipag chemical qauv (daim duab chaw: Uptravi phau ntawv)


Qhov NDA yog ua raws li cov txiaj ntsig tau ntawm ib tus neeg tham txog, ntau qhov kev kawm Ntu 3 kawm. Txoj kev tshawb fawb no txhawm rau ntsuas qhov kev nyab xeeb thiab kev ua siab ntev rau cov neeg mob nrog PAH hloov ntawm qhov ncauj Uptravi mus rau Uptravi IV thiab tom qab ntawd rov qab mus rau qhov pib noj tshuaj.


Cov txiaj ntsig tau qhia tias thaum qhov ncauj Uptravi tsis tuaj yeem ua tiav, Uptravi IV yog qhov tsim nyog rau kev tswj hwm kev tswj hwm ncua sijhawm luv. Kev hloov ntawm Oral Uptravi thiab Uptravi IV tau zoo siab, tsis muaj kev tshawb pom kev nyab xeeb uas tsis tau xav txog. Qhov tshwm sim tsis zoo ntawm Uptravi IV yog zoo ib yam li cov ntawm Uptravi ntsiav tshuaj, tshwj tsis yog rau qhov chaw mob ua kom tsis haum. Prostacyclin-cuam tshuam rau cov tshwm sim muaj xws li mob taub hau, raws plab, xeev siab, ntuav, mob puab tsaig, mob leeg, txhaws caj npab, yaug, thiab mob pob txha.


Dr. Neil Davie, tus thawj coj ntawm thaj chaw kho mob hauv ntiaj teb rau kev mob ntsws ntawm Janssen Kev Tshawb Fawb thiab Kev Txhim Kho, hais tias: kev noj qab haus huv ntawm cov neeg mob. Peb tau ua pov thawj tias Uptravi Kev kho mob tas mus li tuaj yeem txhim kho tus neeg mob ntev li ntawm kev mob ntev. Siv cov tshuaj npaj tiv thaiv kom tsis txhob muaj kev kho mob yog qhov kev xaiv kho mob tseem ceeb, thiab peb zoo siab uas yog ib qib ze dua los nqa cov qauv kev kho mob tseem ceeb no rau PAH cov zej zog."