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Swiss biotech firm Idorsia (SIX: IDIA) today announced the design of its US Food and Drug Administration (FDA)-agreed Phase III registration program for lucerastat in Fabry disease.
Building on the robust biomarker and renal findings from the MODIFY Phase III trial and its long‑term open-label extension (OLE), the program focuses on lucerastat’s impact on renal pathology – a central driver of morbidity and mortality in Fabry disease – with the goal of securing market authorization.
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