Fa'atuai le alualu i luma i le Alzheimer's dementia

A HOLD Fa'asa'oloto 5 | eTurboNews | eTN
Avatar a Linda Hohnholz

O le paaga a BioArctic AB o Eisai na faasilasilaina i le aso e faapea o se tusiga e uiga i taunuuga o le soifua maloloina umi o le suʻesuʻega anti-amyloid-beta (Aβ) protofibril antibody lecanemab (BAN2401) i tagata o loʻo ola i le amataga o le faʻamaʻi o le Alzheimer (AD), e faʻaaoga ai faʻataʻitaʻiga faʻamaʻi, na lomia i totonu. o le tusi talaaga suʻesuʻeina a tupulaga Neurology and Therapy. I lenei faʻataʻitaʻiga, o togafitiga lecanemab e faʻatatau i le faʻagesegese o le faʻatupulaia o faʻamaʻi, faʻatumauina gasegase togafitia mo se taimi umi i taimi muamua o le maʻi.

O loʻo taulaʻi le tusiga i taunuʻuga o falemaʻi umi mo tagata o loʻo nonofo i le amataga o le AD (mud cognitive impairment (MCI) ma le agamalu AD) o loʻo i ai le amyloid pathology, faʻatusatusa le lecanemab faʻatasi ma le tulaga o le tausiga (SoC) ma le SoC naʻo (acetylcholinesterase inhibitor poʻo memantine. ). O le faʻataʻitaʻiga e faʻavae i luga o gasegase o loʻo togafitia seia oʻo i le tulaga AD moderate. O le faʻataʻitaʻiga faʻamaʻi faʻamaʻi (AD ACE model1) e faʻavae i luga o faʻaiuga o le Vaega 2b faʻataʻitaʻiga faʻataʻitaʻiga e iloilo ai le aoga ma le saogalemu o le lecanemab, ma mai suʻesuʻega a le ADNI (Alzheimer's Disease Neuroimaging Initiative).

Lecanemab togafitiga na fuafuaina e faʻagesegese le saoasaoa o faʻamaʻi faʻamaʻi, e mafua ai le umi o le umi o le MCI ona o le AD ma le vaivai AD ma faʻapuʻupuʻu le umi i le AD dementia feololo ma ogaoga. I le faʻataʻitaʻiga o le taimi faʻasolo atu i le laʻititi, feololo, ma le ogaoga o le AD dementia na umi atu mo tagata mamaʻi i le lecanemab-togaina vaega nai lo tagata mamaʻi i le SoC vaega e 2.51 tausaga, 3.13 ma 2.34, faasologa. O le fa'ata'ita'iga fo'i na va'ai mai se fa'aitiitiga o le olaga-taimi e ono mafai ona ulufale i le tausiga fa'alesoifua maloloina fa'atasi ai ma togafitiga lecanemab.

"O taunuʻuga mai le faʻataʻitaʻiga na faia e Eisai o loʻo faʻaalia ai le aoga o le lecanemab mo tagata mamaʻi i le amataga o le AD ma pe faʻafefea ona faʻagesegese le saoasaoa o faʻamaʻi faʻamaʻi, faʻatuai le alualu i luma i le AD dementia ma le tele o tausaga ma faʻaitiitia le manaʻomia mo tausiga faʻapitoa. O su'esu'ega fa'apenei e taua tele ina ia malamalama ai i a'afiaga umi mo ma'i, aiga ma sosaiete e ofoina mai e le lecanemab togafitiga e sili atu nai lo mea e mafai ona va'aia i su'esu'ega falema'i. O le taunuuga o le Clarity AD Phase 3 suʻesuʻega o le a taua tele mo le faʻaleleia atili o lenei faʻataʻitaʻiga, ma o loʻo matou tulimatai atu i le pito i luga mulimuli ane i lenei tausaga, "o le tala lea a Gunilla Osswald, BioArctic's CEO.

Lecanemab na faʻatagaina le Breakthrough Therapy ma le Fast Track e le US Food and Drug Administration (FDA) ia Iuni ma Tesema 2021, i le faasologa. O lo'o fa'amoemoe Eisai e fa'amae'aina le tu'uina atu a le lecanemab o se Talosaga Laisene Biologics mo le togafitiga o le amataga o le AD i le FDA i lalo o le auala fa'avavevave fa'atagaina i le kuata lona lua 2022. E le gata i lea, o le faitauga o le Vaega 3 fa'amaonia Clarity AD fa'ata'ita'iga fa'apitoa e fa'amoemoe i le fa'ai'uga o Setema 2022. Na amataina e Eisai se talosaga i le Pharmaceuticals and Medical Devices Agency (PMDA) o faʻamaumauga o talosaga o le lecanemab i lalo o le faiga faʻatalanoaga muamua i Iapani ia Mati 2022.

Lenei tatalaina talanoaina talanoaga suʻesuʻe o se sooupu i atinae ma e le fuafuaina e faʻailoa atu faaiuga e uiga i le aoga poʻo le saogalemu. E leai se faʻamaoniga o soʻo se suʻesuʻega faʻaaogaina o ia oloa o le a faʻamaeʻaina lelei atinaeina falemai pe maua ai le soifua maloloina pulega faʻamaonia.

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Avatar a Linda Hohnholz

Linda Hohnholz

Faatonu sili mo eTurboNews fa'avae ile eTN HQ.

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