Izilwa-buhlungu ze-Monoclonal (mAbs) i-lecanemab kunye ne-donanemab zamkelwe kunyango lwe-Alzheimer's kwangoko e-UK nase-USA ngokulandelelana ngelixa i-lecanemab yaliwe isigunyaziso sentengiso kwi-EU ngenxa yokhuseleko “olunganelisiyo” kunye neenkcukacha ezisebenzayo ezivela kulingo lwezonyango. I-NICE, iqumrhu likarhulumente e-UK elijongene nokuvavanya ubungqina bobuchwepheshe obutsha bezempilo ukuze kuqinisekiswe ixabiso lomhlawuli werhafu, ucinga ukuba izibonelelo ze-lecanemab zincinci kakhulu ukulungelelanisa iindleko kwi-NHS. Inikwe, Isifo se-Alzheimer sisifo esixhaphakileyo se-neurodeergenerative esibonakala ngokuhla okuqhubekayo kwimemori kwaye malunga ne-4% yabantu abaneminyaka eyi-60 + iminyaka kwihlabathi jikelele bayachaphazeleka (5.4 % eNtshona Yurophu kunye ne-6.4 % kuMntla Melika), ukuvunywa kwee-antibodies ezimbini ze-monoclonal kunyango lwe-Alzheimer yokuqala inikezela. ithemba lokuphucula umgangatho wobomi (QoL) wabantu abachaphazelekayo.
Ngomhla wama-22 ku-Agasti ka-2024, i-Arhente yoLawulo lwaMayeza kunye nezeMpilo (MHRA) yase-UK ivume i-lecanemab ukuba isetyenziswe kumanqanaba okuqala Isifo se-Alzheimer (AD). Olu lunyango lokuqala lwesifo sika-Alzheimer olunelayisensi yokusetyenziswa eUnited Kingdom.
I-Lecanemab sisilwanyane sokuzikhusela kwi-monoclonal (mAbs). Ilibazisa ukuba mandundu kweempawu zesifo i-Alzheimer ngokuncamathela kwi-amyloid beta ukunciphisa amacwecwe ebuchotsheni. Ibonise ubungqina obuthile bokusebenza ekunciphiseni ukuqhubela phambili kwesifo kwiimvavanyo zeklinikhi.
Nangona kunjalo, iNational Institute for Health and Care Excellence (NICE), iqumrhu likarhulumente elijongene nokuvavanya ubungqina betekhnoloji entsha yezempilo yokuqinisekisa ixabiso lomhlawuli werhafu, licinga ukuba izibonelelo ze-lecanemab zincinci kakhulu ukulungelelanisa iindleko kwi-NHS.
INkonzo yezeMpilo yeSizwe (NHS) yinkqubo yehlabathi jikelele exhaswa ngemali ngaphandle kwerhafu jikelele. Ibonelela ngeenkonzo zempilo kuye wonke umntu, simahla kwindawo yokuhanjiswa ngokusekelwe kwimfuno yokhathalelo lwempilo (kwaye ayisekelwanga kwisakhono sokwenza intlawulo). I-NICE yenza uhlalutyo olusebenzayo lweendleko (CEA) kunyango olutsha kwaye ibonelela ngezikhokelo zeklinikhi kwi-NHS. Izibonelelo zonyango olutsha kufuneka zibe zilungile ngokwaneleyo ukuthethelela iindleko ngaphambi kokuba zivunywe kwi-NHS. Uyilo lwengcebiso ye-NICE malunga ne-lecanemab (okt, "Iinzuzo zonyango lwe-Alzheimer's lecanemab zincinci kakhulu ukuba zingathethelela iindleko ze-NHS") kuthetha ukuba i-lecanemab ayizukufumaneka kwizigulana ze-NHS. Nangona kunjalo, abaguli babucala banokulufumana unyango lwe-lecanemab xa besenza intlawulo epokothweni yokhathalelo.
Kwangoko nge-25 kaJulayi 2024, i-Arhente yaMayeza yaseYurophu (EMA) yala ugunyaziso lokuthengisa iLeqembi (into esebenzayo: lecanemab) yonyango lwe Isifo se-Alzheimer. I-EMA yayinenkxalabo kukhuseleko kunye nokusebenza kakuhle. Lilonke, i-arhente ifumanise ukuba izibonelelo zonyango azikho zikhulu ngokwaneleyo ukodlula imingcipheko kungoko kwaliwe. Ukusukela nge-5 ka-Agasti ka-2024, inkampani yaseLeqembi iye yacela ukuphononongwa kwakhona koluvo lokwala.
E-USA, i-Kisunla (i-donanemab-azbt; njenge-lecanemab, i-donanemab nayo i-antibody ye-monoclonal ebophelela kwi-amyloid ebuchosheni kunye nokunciphisa iimpawu) yamkelwe kunyango lwe-Alzheimer's disease nge-02 Julayi 2024. Iboniswa kwizigulane ezinobumnene. ukuphazamiseka kwengqondo okanye inqanaba elisezantsi le-dementia Isifo se-Alzheimer.
Isifo sika-Alzheimer sisifo se-neurodeergenerative esixhaphakileyo esibonakaliswa kukwehla okuqhubelekayo kwinkumbulo. Imisebenzi yengqondo enjengokucinga, ukufunda kunye nezakhono zokulungelelanisa ziyachaphazeleka. Malunga ne-4 % yabantu abaneminyaka eyi-60 + iminyaka kwihlabathi jikelele abachaphazelekayo. Ukuxhaphaka kweNtshona Yurophu nakuMntla Melika yi-5.4 % kunye ne-6.4 % ngokulandelelanayo. Ukuvunywa kwee-antibodies ezimbini ze-monoclonal, i-Lecanemab e-UK kunye ne-donanemab e-USA, kunyango lwe-Alzheimer yokuqala yesifo inikezela ukhetho kunye nethemba lokuphucula umgangatho wobomi (QoL) kubantu abachaphazelekayo. Nokuba "obunye" ubungqina bokusebenza sisiqalo esamkelekileyo.
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Iingxelo:
- van Dyck, CH et al. Lecanemab kwiSifo se-Alzheimer yasekuqaleni. N. IsiNgesi. J. Med. 388, 9–21 (2023). DOI: https://doi.org/10.1056/NEJMoa2212948
- MHRA. Ukukhutshwa kweendaba-iLecanemab enikwe ilayisenisi kwizigulana zabantu abadala kumanqanaba okuqala esifo i-Alzheimer's. Ithunyelwe nge-22 Agasti 2024. Iyafumaneka e https://www.gov.uk/government/news/lecanemab-licensed-for-adult-patients-in-the-early-stages-of-alzheimers-disease
- INTLE. Iindaba – Izibonelelo zonyango lwe-Alzheimer entsha i-lecanemab zincinci kakhulu ukuba zingathethelela iindleko ze-NHS. Ithunyelwe nge-22 Agasti 2024. Iyafumaneka e https://www.nice.org.uk/news/articles/benefits-of-new-alzheimer-s-treatment-lecanemab-are-too-small-to-justify-the-cost-to-the-nhs
- I-Arhente yaMayeza yaseYurophu. Leqembi. Hlaziya ukususela nge-5 Agasti 2024. Ifumaneka apha https://www.ema.europa.eu/en/medicines/human/EPAR/leqembi
- I-FDA iyaluvuma unyango lwabantu abadala abanesifo sika-Alzheimer https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-treatment-adults-alzheimers-disease
- I-KISUNLA (donanemab-azbt) inaliti, yokusetyenziswa emithanjeni Imvume yokuqala yase-US: 2024 https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761248s000lbl.pdf
- I-Espay AJ, i-Kepp KP, i-Herrup K. Lecanemab kunye ne-Donanemab njengoNyango lwe-Alzheimer's Disease: Umbono oMzobo kwiiNkcukacha. eNeuro. 2024 Jul 1;11(7):ENEURO.0319-23.2024. DOI: https://doi.org/10.1523/ENEURO.0319-23.2024
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