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Novartis LABA / LAMA / ICS cov khoom muag Enerzair Breezhaler tau txais kev pom zoo los ntawm European Union, thiab nws cov txiaj ntsig tau yeej Shulidie!

[Jul 16, 2020]

Novartis tsis ntev los no tshaj tawm tias Cov European Commission (EC) tau pom zoo Enerzair Breezhaler (QVM149; indacaterol acetate / glycopyrronium bromide / mometasone furoate, IND / GLY / MF) raws li kev saib xyuas kho kom tau txais kev ua haujlwm ntev β2 receptor agonism (LABA) thiab siab koob tshuaj txau corticosteroid (ICS) kev sib xyaw nrog kev tswj kev saib xyuas tsis tuaj yeem tswj tau tus kab mob tag nrho, thiab tau ntsib ib lossis ntau qhov mob ntawm cov mob hawb pob (mob hawb pob heev dhau los) hauv xyoo dhau los. Kev pom zoo kuj suav nrog thawj tus khub digital (sensors thiab apps) muab cov ntaub ntawv ua pa, qhia kev nco qab txog tshuaj noj, thiab nkag mus rau cov ntaub ntawv hom phiaj los txhawb kev txiav txim siab txog kev kho mob kom zoo dua. Kev txiav txim siab pom zoo hauv EC siv rau txhua lub 27 EU tus tswvcuab hauv tebchaws Askiv, Tebchaws Askiv, Iceland, Norway, thiab Liechtenstein.


Enerzair Breezhaler yog muaj li ntawm indacaterol acetate (IND, LABA), glycopyrronium bromide (GLY, lub cev ntev muscarinic receptor antagonist [LAMA]), mometasone furoate (MF, koob tshuaj ICS) Ua los ntawm cov khoom sib xyaw ua ke uas muaj cov tshuaj tiv thaiv. raug tseeb ua ke ntawm cov nyhuv bronchodilator ntawm IND nrog cov tshuaj anti-muscarinic ntawm GLY thiab cov tshuaj tiv thaiv kev cuam tshuam ntawm qib siab ICS. Enerzair Breezhaler siv cov tshuaj Breezhaler nrog kev paub tseeb koob tshuaj los tswj cov tshuaj, uas tso cai rau ib lub tshuaj txau ib zaug nqus ib hnub ib zaug rau kev kho mob.


Nws tsim nyog teev tias Enerzair Breezhaler yog thawj zaug-txhua hnub LABA / LAMA / ICS cov tshuaj sib xyaw ua ke muaj cov khoom pom zoo hauv Tebchaws Europe. Nws tseem yog thawj tus EU-tshaj rau cov khub (Propeller Health sensor thiab daim ntawv thov raug rau Breezhaler li Cov Txheej Txheem) Cov txheej txheem kho mob hawb pob tau zoo ua ke. Tus khub digital no tuaj yeem muab cov neeg mob nrog kev nqus tau cov lus pom zoo, kom nco qab txog tshuaj, thiab nkag mus rau cov ntaub ntawv kho hom phiaj, uas tuaj yeem sib koom nrog cov kws kho mob kom pab kws kho mob txiav txim siab txog kev kho mob zoo dua.


Qhov kev pom zoo no yog saib raws li kev ua tau zoo thiab kev nyab xeeb cov ntaub ntawv los ntawm ntau dua 3,000 tus neeg mob hawb pob hauv theem III IRIDIUM txoj kev tshawb fawb. Txoj kev tshawb no pom tau hais tias piv nrog Atectura Breezhaler (QMF149, IND / MF, indacaterol acetate / mometasone furoate), kev kho mob Enerzair Breezhaler tau ua tiav kev sib raug zoo hauv cov neeg mob' lub ntsws ua haujlwm.


Hauv qhov kev tshawb fawb no, qhov tseem ceeb kawg ntawm qhov kawg yog piv rau Enerzair Breezhaler thiab Atectura Breezhaler' s kev txhim kho hauv daim ntawv nug txog kev tswj hwm ua tsis taus pa (ACQ-7) cov qhab nia. Cov ntaub ntawv qhia tau hais tias thaum 26 lub lim tiam ntawm kev kho mob, ob txoj kev kho mob tau pom tias muaj txiaj ntsig zoo los ntawm lub hauv paus, tab sis tsis ncav cuag qhov tseem ceeb kawg qhov kawg. Hauv kev txheeb xyuas ntawm lwm qhov kawg ntawm qhov kawg, IRIDIUM txoj kev tshawb nrhiav pom qhov mob ua rau mob hawb pob, piv nrog kev paub txog LABA / ICS cov kev saib xyuas (salmeterol / fluticasone propionate [Advair, Shulidi], 2 zaug hauv ib hnub), kev kho mob hauv Enerzair Breezhaler ua rau txo tus mob exacerbation mob sib khuav ntawm tus mob mus rau mob ntsws asthma. Cov txiaj ntsig kev nyab xeeb hauv qhov kev kawm no yog ua tau raws cov kev paub ib ntu tiv thaiv kev nyab xeeb.


Tam sim no, Enerzair Breezhaler (IND / GLY / MF) tau pom zoo ib hnub ib zaug hauv Nyij Pooj thiab Canada. Ib hnub ib zaug Atectura Breezhaler (IND / MF) tau pom zoo nyob hauv European Union, Nyij Pooj, Canada, cov tshuaj yog LABA / ICS kev sib xyaw-koob tshuaj, ua kev kho kev kho mob rau kev kho mob ntawm ≥12 xyoo, tau txais kev nqus dej cortex Steroids (ICS) thiab nqus tau luv luv ua yeeb yaj kiab receptor agonists (SABA) tsis txaus tswj cov neeg laus thiab tub ntxhais hluas asthmatics.


Novartis tau cog lus yuav nqa Enerzair Breezhaler (IND / GLY / MF) thiab Atectura Breezhaler (IND / MF) rau cov neeg mob thoob ntiaj teb. Ob yam khoom no tam sim no tab tom tshawb xyuas cov kev tswj xyuas hauv ntau lub tebchaws, suav nrog Switzerland. Raws li Novartis txuas ntxiv ua kom muaj kev txo qis ib puag ncig ntawm kev mob hawb pob ua ke, ob yam khoom yuav raug tswj hwm los ntawm Breezhaler® ntaus ntawv, uas tsis siv hydrofluorocarbon / chlorofluorocarbon (HFA / CFC).


Rod Wooten, tus thawj coj ntawm kev lag luam thoob ntiaj teb rau Novartis Cov Chaw Muag Tshuaj, hais tias:" Kev pom zoo ntawm Enerzair Breezhaler thiab Digital Partners nyob rau hauv EU yog peb kev cog lus rau kev siv cov ntaub ntawv Thiab cov khoom lag luam digital ua rau mob hawb pob tswj cov piv txwv ntawm cov neeg mob thiab kws kho mob tuaj yeem ua tiav."


Professor David Price, tus thawj coj ntawm Lub Tsev Haujlwm Saib Xyuas Kev Noj Qab Haus Huv thiab Chaw Kho Mob ntawm Lub Tsev Kawm Ntawv Qib Siab University of Aberdeen, UK tau hais tias," Tam sim no, ntau dua 45% ntawm cov neeg mob hawb pob hauv GINA qib 4 thiab 5 tseem tsis tuaj yeem tswj tau, uas qhia tau qhov xav tau cov tshuaj tshiab, cov txheej txheem kev tswj hwm, thiab kev txhawb nqa tus neeg mob Los saib xyuas cov tshuaj kom raug thiab ua tiav lub hom phiaj kho. Ib hnub ib zaug, Enerzair Breezhaler sib koom ua ke nrog tus khub digital yuav pab tau EU cov kws kho mob thiab cov neeg mob hawb pob tsis tuaj yeem tswj tau tus kab mob txawm hais tias kev kho mob LABA / ICS kom muaj kev sib koom tes zoo dua hauv kev tswj kab mob. Cov."