Klartecken i USA – Immedica får accelererat godkännande

FDA har gett Immedica ett accelererat godkännande för läkemedlet Loargys, för patienter med den ovanliga ämnesomsättningssjukdomen arginas 1-brist (ARG1-D).

By Lotta Naesenius

February 24, 2026 9:53 AM

Det svenska särläkemedelsbolaget Immedica har sedan 2023 haft ett godkännande i EU för Loargys (pegzilarginase-nbln). Nu får bolaget även klartecken i USA genom ett så kallat accelererat godkännande från FDA. Beslutet gäller behandling av hyperargininemi hos patienter från två års ålder med arginas 1-brist.

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