Abokin tarayya na BioArctic AB Eisai ya sanar a yau cewa an buga labarin game da sakamakon lafiya na dogon lokaci na binciken anti-amyloid-beta (Aβ) protofibril antibody lecanemab (BAN2401) a cikin mutanen da ke fama da cutar Alzheimer na farko (AD), ta amfani da ƙirar cuta, an buga su a cikin Mujallar Neurology da Therapy da aka sake dubawa ta tsara. A cikin wannan simintin, ana ƙididdige jiyya na lecanemab don rage yawan ci gaban cutar, da kiyaye marasa lafiya da aka jiyya na tsawon lokaci a farkon matakan cutar.

Labarin yana mayar da hankali kan sakamakon asibiti na dogon lokaci ga mutanen da ke zaune tare da farkon AD (MCI) da kuma m AD waɗanda ke da ilimin amyloid, kwatanta lecanemab tare da daidaitattun kulawa (SoC) tare da SoC kadai (acetylcholinesterase inhibitor ko memantine). ). Kwaikwayon ya dogara ne akan marasa lafiya da ake yi musu magani har sai sun kai matsakaicin matakin AD. Misalin simintin cutar (AD ACE model1) ya dogara ne akan sakamakon gwajin gwaji na Phase 2b wanda ke kimanta inganci da amincin lecanemab, kuma daga ADNI (Alzheimer's Disease Neuroimaging Initiative) sakamakon binciken.

An kiyasta jiyya na Lecanemab don rage yawan ci gaban cututtuka, wanda ya haifar da tsawon lokaci na MCI saboda AD da rashin jinƙai AD kuma ya rage tsawon lokaci a cikin matsakaici da matsananciyar lalata AD. A cikin ƙirar ma'anar lokacin haɓakawa zuwa m, matsakaici, da matsananciyar lalata AD ya fi tsayi ga marasa lafiya a cikin rukunin da aka yi wa lecanemab fiye da na marasa lafiya a cikin ƙungiyar SoC ta shekaru 2.51, 3.13 da 2.34, bi da bi. Hakanan samfurin ya annabta ƙarancin yuwuwar lokacin rayuwa na shiga cikin kulawar hukuma tare da jiyya na lecanemab.

"Sakamako daga simintin da Eisai ya yi ya nuna yuwuwar ƙimar asibiti na lecanemab ga marasa lafiya tare da farkon AD da kuma yadda zai iya rage saurin ci gaban cutar, jinkirta ci gaba zuwa cutar dementia AD tare da shekaru da yawa da kuma rage buƙatar kulawar hukuma. Nazari irin waɗannan suna da mahimmanci don fahimtar yuwuwar tasirin dogon lokaci ga majiyyaci, iyalai da al'umma waɗanda jiyya na lecanemab ke bayarwa fiye da abin da za a iya gani a gwaji na asibiti. Sakamakon binciken Clarity AD Phase 3 zai zama mahimmanci don ƙara inganta wannan ƙirar, kuma muna sa ran samun sakamako mafi girma daga baya a wannan shekara, "in ji Gunilla Osswald, Shugabar BioArctic.

Hukumar Abinci da Magunguna ta Amurka (FDA) ta ba Lecanemab Breakthrough Therapy and Fast Track a cikin Yuni da Disamba 2021, bi da bi. Eisai yana tsammanin kammala ƙaddamar da mirginawar lecanemab na Aikace-aikacen Lasisi na Biologics don kula da farkon AD ga FDA a ƙarƙashin ingantacciyar hanyar yarda a cikin kwata na biyu 2022. Bugu da ƙari, ana sa ran karatun matakin 3 na tabbatar da Clarity AD gwajin asibiti a ƙarshen Satumba. 2022. Eisai ya qaddamar da biyayya ga Pharmaceuticals and Medical Devices Agency (PMDA) na bayanan aikace-aikacen lecanemab a ƙarƙashin tsarin tuntuɓar tuntuɓar kima a Japan a cikin Maris 2022.

Wannan sakin yana magana ne akan amfanin bincike na wakili a cikin haɓakawa kuma ba a yi niyya don isar da sakamako game da inganci ko aminci ba. Babu tabbacin cewa duk wani amfani na bincike na irin wannan samfurin zai sami nasarar kammala ci gaban asibiti ko samun amincewar ikon lafiya.

ABUBUWAN DA ZA KU GUDU DAGA WANNAN LABARI:

Lecanemab treatment was estimated to slow the rate of disease progression, resulting in an extended duration of MCI due to AD and mild AD dementia and shortened the duration in moderate and severe AD dementia.
“The results from the simulation done by Eisai demonstrate the potential clinical value of lecanemab for patients with early AD and how it could slow the rate of disease progression, delay progression to AD dementia with several years and reduce the need for institutionalized care.
In the model the mean time advancing to mild, moderate, and severe AD dementia was longer for patients in the lecanemab-treated group than for patients in the SoC group by 2.