Nem kapott engedélyt az Alzheimer-gyógyszer
Pöltz Ágnes
2021.12.19. 16:05
Az Európai Gyógyszerügynökség (EMA) humángyógyszerészeti bizottságának (CHMP) decemberi ülésén elutasítást nyert az aducanumab (Aduhelm, Biogen) ellentmondásos Alzheimer-gyógyszerének forgalmazási kérelme.
A CHMP egy novemberi meetingjén már az engedély megtagadása ellen szavazott, így a végső döntés nem jelentett meglepetést.
A bizottság megjegyzése szerint ugyan az aducanumab valóban csökkenti az amyloid béta jelenlétét az agyban, mindez a klinikai javulással nem mutat egyelőre megalapozott kapcsolatot.
A szakértők továbbá úgy érezték, hogy a gyógyszervizsgálatok eredményei ellentmondásosak és nem szolgáltatnak perdöntő bizonyítékot arra vonatkozóan, hogy a szer hatékony lenne a korai Alzheimer-kór kezelésében.
A bizottság hozzátette, hogy a biztonságosság kitétele is megkérdőjelezhető, mivel egyes betegek agyi képalkotó vizsgálatain olyan abnormális jeleket találtak, amik az agy duzzanatára vagy vérzésre utalhattak, és amik potenciálisan károsak lehetnek. Kiemelték, hogy a klinikai gyakorlatban ezeket az abnormalitásokat nem monitorozzák.
Mindezek nyomán a bizottság arra a következtetésre jutott, hogy az aducanumab előnyei nincsenek túlsúlyban a kockázatokkal szemben és ennek nyomán nem javasolhatják piaci forgalmazásra a szert.
A szer gyártója, a Biogen a negatív vélemény kézhez kapását követő tizenöt napon belül felülvizsgálatot kérelmezhet.
Idén júniusban Amerikában az Élelmiszer- és Gyógyszerbiztonsági Hivatal (FDA) jóváhagyta az amyloid-ellenes gyógyszer használatát a korai Alzheimer-kór kezelésében – annak ellenére, hogy a szakértői bizottságuk itt is az engedély ellenében érvelt.
Több hétnyi hangos vita és felháborodást követően egy hónappal később az FDA megbízott vezetője, Dr. Janet Woodcock amerikai szövetségi nyomozást kérvényezett a saját intézményük engedélyezési gyakorlatának kivizsgálására.
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