Avgörande beslut om lecanemab skjuts upp – igen

Turerna kring ett eventuellt EU-godkännande för svenskutvecklade alzheimerläkemedlet lecanemab tycks aldrig ta slut. Nu har EU-kommissionen i en ovanlig åtgärd beslutat att hänskjuta avgörandet till omprövningskommittén.

By Anders Göransson

April 1, 2025 12:45 PM

När EMA lämnat ett positivt omdöme om ett läkemedel är själva godkännandet från EU-kommissionen normalt en formalitet. Men i fallet lecanemab (Leqembi) har det sett annorlunda ut.

Läkemedlet, som redan har marknadsgodkänts i USA och på flera andra marknader, har fått en betydligt snirkligare väg mot ett potentiellt grönt ljus i EU.

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