I-Lecanemab yeSifo se-Alzheimer yasekuqaleni yamkelwe e-UK kodwa yala kwi-EU 

Ii-antibodies ze-monoclonal (mAbs) i-lecanemab kunye ne-donanemab zivunyiwe ukunyanga isifo se-Alzheimer's e-UK nase-USA ngokwahlukeneyo ngelixa i-lecanemab iye ayalelwa imvume yokuthengisa kwi-EU ngenxa yedatha "enganelisiyo" yokhuseleko kunye nokusebenza kakuhle evela kuvavanyo lweklinikhi. I-NICE, iqumrhu likarhulumente e-UK elinoxanduva lokuvavanya ubungqina betekhnoloji entsha yezempilo ukuqinisekisa ixabiso lomhlawuli werhafu, licinga ukuba iingenelo ze-lecanemab zincinci kakhulu ukuba zilungele iindleko kwi-NHS. Njengoko, isifo se-Alzheimer sisifo esiqhelekileyo se-neurodegenerative esibonakaliswa kukuncipha kwenkumbulo okuqhubekayo kwaye malunga ne-4% yabantu abaneminyaka engama-60 nangaphezulu kwihlabathi liphela bayachaphazeleka (5.4% eNtshona Yurophu kunye ne-6.4% eMntla Melika), ukuvunywa kwee-antibodies ezimbini ze-monoclonal zokunyanga isifo se-Alzheimer's ekuqala kunika ithemba lokuphucula umgangatho wobomi (QoL) wabantu abachaphazelekayo.

Ngomhla wama-22 kweyeThupha ngo-2024, i-Medicines and Healthcare products Regulatory Agency (MHRA) yase-UK yavuma i-lecanemab ukuba isetyenziswe kwizigaba zokuqala zesifo sika-Alzheimer (AD). Olu lolona nyango lokuqala lwesifo sika-Alzheimer olunelayisenisi yokusetyenziswa e-United 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 (i-NHS) yinkqubo exhaswa nguwonke-wonke ngemali yerhafu eqhelekileyo. Ibonelela ngeenkonzo zempilo kuye wonke umntu, simahla kwindawo yokunikezelwa kweenkonzo ngokusekelwe kwimfuno yezempilo (kwaye ayisekelwanga kubuchule bokuhlawula). I-NICE yenza uhlalutyo lokusetyenziswa kakuhle kweendleko (i-CEA) kunyango olutsha kwaye ibonelela ngezikhokelo zeklinikhi ze-NHS. Iingenelo zonyango olutsha kufuneka zibe zilungile ngokwaneleyo ukuthethelela iindleko ngaphambi kokuba zivunywe kwi-NHS. Ingcebiso eyiliweyo ye-NICE malunga ne-lecanemab (oko kukuthi, "iingenelo zonyango olutsha lwe-Alzheimer's lecanemab zincinci kakhulu ukuthethelela iindleko kwi-NHS" ) ithetha ukuba i-lecanemab ayizukufumaneka kwizigulane ze-NHS. Nangona kunjalo, izigulana zabucala zingalufumana unyango lwe-lecanemab xa zihlawula unyango ngepokotho.

Ngaphambili ngomhla wama-25 kuJulayi 2024, i-European Medicines Agency (EMA) yala imvume yokuthengisa yeLeqembi (isithako esisebenzayo: i-lecanemab) yokunyanga isifo se-Alzheimer . I-EMA yayinenkxalabo malunga nokhuseleko kunye nokusebenza kakuhle. Ngokubanzi, i-arhente ifumanise ukuba izibonelelo zonyango azinkulu ngokwaneleyo ukuba zingadlula iingozi ngenxa yoko kwaliwa. Ukususela ngomhla wesi-5 ku-Agasti 2024, inkampani yeLeqembi icele ukuba kuhlolwe kwakhona uluvo lokwaliwa.

E-USA, iKisunla (i-donanemab-azbt; njenge-lecanemab, i-donanemab nayo yi-antibody ye-monoclonal ebopha kwi-amyloid engqondweni kwaye inciphise iimpawu) yavunywa ukunyanga isifo se-Alzheimer ngomhla wesi-02 kweyeKhala ngo-2024. Iboniswa kwizigulana ezine-mild cognitive impairment okanye i-mild dementia stage yesifo 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:  

1. 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  

2. 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  

3. 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  

4. I-Arhente yaMayeza yaseYurophu. Leqembi. Hlaziya ukususela nge-5 Agasti 2024. Ifumaneka apha https://www.ema.europa.eu/en/medicines/human/EPAR/leqembi  

5. I-FDA iyaluvuma unyango lwabantu abadala abanesifo sika-Alzheimer https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-treatment-adults-alzheimers-disease 

6. I-KISUNLA (donanemab-azbt) inaliti, yokusetyenziswa emithanjeni Imvume yokuqala yase-US: 2024 https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761248s000lbl.pdf  

7. 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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