Amasosha omzimba e-Monoclonal (mAbs) i-lecanemab kanye ne-donanemab agunyazwe ukwelashwa kwesifo i-Alzheimer's ekuqaleni e-UK nase-USA ngokulandelana kuyilapho i-lecanemab yenqatshelwe ukugunyazwa ukumaketha e-EU ngenxa yedatha “engagculisi” yokuphepha nempumelelo evela ezivivinyweni zomtholampilo. I-NICE, inhlangano yomphakathi e-UK enesibopho sokuhlola ubufakazi bobuchwepheshe obusha bezempilo ukuze kuqinisekiswe inani lomkhokhintela, icabanga ukuthi izinzuzo ze-lecanemab zincane kakhulu ukuthi zingakwazi ukuthethelela izindleko ze-NHS. Inikezwe, Isifo i-Alzheimer kuyisifo esivamile se-neurodeergenerative esibonakala ngokuncipha okuqhubekayo kwenkumbulo futhi cishe abantu abangu-4 % abaneminyaka engu-60+ iminyaka emhlabeni wonke bayathinteka (5.4 % eNtshonalanga Yurophu kanye no-6.4 % eNyakatho Melika), ukugunyazwa kwamasosha omzimba amabili e-monoclonal ekwelapheni isifo i-Alzheimer's ekuqaleni kunikezwa. ithemba lokuthuthuka kwezinga lempilo (QoL) labantu abathintekile.
Ngomhla zingama-22 ku-Agasti 2024, i-Medicines and Healthcare Products Regulatory Agency (MHRA) yase-UK yagunyaza i-lecanemab ukuthi isetshenziswe ekuqaleni Isifo i-Alzheimer (AD). Lokhu ukwelashwa kokuqala kwesifo i-Alzheimer okugunyazwe ukusetshenziswa e-United Kingdom.
I-Lecanemab iyi-antibody ye-monoclonal (mAbs). Ibambezela ukuwohloka kwezimpawu zesifo i-Alzheimer ngokunamathisela ku-amyloid beta ukuze kuncishiswe ama-plaque ebuchosheni. Ibonise ubufakazi obuthile bokusebenza ngempumelelo ekubambezeleni ukuqhubeka kwesifo ekuhlolweni komtholampilo.
Kodwa-ke, i-National Institute for Health and Care Excellence (NICE), indikimba yomphakathi ebhekele ukuhlola ubufakazi bobuchwepheshe obusha bezempilo ukuze kuqinisekiswe inani lomkhokhintela, icabanga ukuthi izinzuzo ze-lecanemab zincane kakhulu ukuthi zingakwazi ukuthethelela izindleko ze-NHS.
Isevisi Yezempilo Kazwelonke (NHS) iwuhlelo lomhlaba wonke oluxhaswe esidlangalaleni ngaphandle kwentela evamile. Ihlinzeka ngezinsizakalo zezempilo kuwo wonke umuntu, mahhala ngesikhathi sokulethwa ngokusekelwe esidingweni sokunakekelwa kwezempilo (hhayi ngokusekelwe emandleni okukhokha). I-NICE yenza ukuhlaziya ukusebenza kahle kwezindleko (i-CEA) ukuze uthole ukwelashwa okusha futhi inikeza imihlahlandlela yomtholampilo ye-NHS. Izinzuzo zokwelashwa okusha kufanele zibe zinhle ngokwanele ukuthethelela izindleko ngaphambi kokuba zigunyazwe ku-NHS. Isincomo esisalungiswa se-NICE mayelana ne-lecanemab (okungukuthi, "izinzuzo zokwelashwa okusha kwe-Alzheimer's lecanemab zincane kakhulu ukuthi zingakwazi ukukhokhela izindleko ze-NHS") kusho ukuthi i-lecanemab ngeke itholakale ezigulini ze-NHS. Kodwa-ke, iziguli ezizimele zingasebenzisa ukwelashwa kwe-lecanemab lapho zenza inkokhelo ephaketheni yokunakekelwa.
Ngaphambilini ngomhla ka-25 Julayi 2024, i-European Medicines Agency (EMA) yenqabile ukugunyazwa ukumaketha kwe-Leqembi (into esebenzayo: lecanemab) yokwelashwa Isifo i-Alzheimer. I-EMA ibinokukhathazeka kukho kokubili ukuphepha nokusebenza ngempumelelo. Sekukonke, i-ejensi ithole ukuthi izinzuzo zokwelashwa azinkulu ngokwanele ukudlula ubungozi yingakho nokwaliwa. Kusukela mhla zi-5 kuNcwaba wezi-2024, inkampani yakwaLeqembi icele ukuphinde kubhekwe umbono wokwenqaba.
E-USA, i-Kisunla (i-donanemab-azbt; njenge-lecanemab, i-donanemab nayo iyi-monoclonal antibody ebophezela ku-amyloid ebuchosheni futhi yehlise izimpawu) yagunyazwa ukwelapha isifo i-Alzheimer's ngomhla zi-02 kuJulayi 2024. Ikhonjiswe ezigulini ezinobuthakathaka obuncane. ukukhubazeka kwengqondo noma isigaba sokuwohloka komqondo okuncane Isifo i-Alzheimer.
Isifo i-Alzheimer's yisifo esivamile se-neurodegenerative esibonakala ngokuncipha okuqhubekayo kwenkumbulo. Imisebenzi yengqondo enjengokucabanga, amakhono okufunda nokuhlela iyathinteka. Cishe u-4% wabantu abaneminyaka engu-60+ emhlabeni wonke bayathinteka. Ukusabalala eNtshonalanga Yurophu naseNyakatho Melika kungu-5.4 % no-6.4 % ngokulandelana. Ukugunyazwa kwamasosha omzimba amabili e-monoclonal, i-Lecanemab yase-UK kanye ne-donanemab e-USA, ukuze kwelashwe isifo i-Alzheimer's ekuqaleni kunikeza inketho nethemba lokuthuthuka kwezinga lempilo (QoL) kubantu abathintekile. Ngisho nobufakazi "obunye" bokusebenza buyisiqalo esamukelekayo.
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References:
- van Dyck, CH et al. I-Lecanemab ku-Early Alzheimer's Disease. N. IsiNgisi. J. Med. 388, 9–21 (2023). I-DOI: https://doi.org/10.1056/NEJMoa2212948
- I-MHRA. Ukukhishwa kwabezindaba - I-Lecanemab ilayisensi yeziguli ezikhulile ezisezigabeni zokuqala zesifo i-Alzheimer's. Kuthunyelwe ngomhla ka-22 Agasti 2024. Itholakala e- https://www.gov.uk/government/news/lecanemab-licensed-for-adult-patients-in-the-early-stages-of-alzheimers-disease
- KUHLE. Izindaba – Izinzuzo zokwelashwa kwe-Alzheimer entsha i-lecanemab zincane kakhulu ukuthi zingakwazi ukuthethelela izindleko ze-NHS. Kuthunyelwe ngomhla ka-22 Agasti 2024. Itholakala 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-European Medicines Agency. Leqembi. Buyekeza kusukela ngomhla ka-5 Agasti 2024. Itholakala kokuthi https://www.ema.europa.eu/en/medicines/human/EPAR/leqembi
- I-FDA igunyaza ukwelashwa kwabantu abadala abanesifo i-Alzheimer's https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-treatment-adults-alzheimers-disease
- I-KISUNLA (donanemab-azbt) umjovo, wokusetshenziswa emthanjeni Imvume Yokuqala yase-US: 2024 https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761248s000lbl.pdf
- I-Espay AJ, Kepp KP, Herrup K. Lecanemab kanye ne-Donanemab Njengemithi Yokwelapha I-Alzheimer's Disease: Umbono Onemifanekiso Kudatha. eNeuro. 2024 Jul 1;11(7):ENEURO.0319-23.2024. I-DOI: https://doi.org/10.1523/ENEURO.0319-23.2024
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