FABHALTA

批准信原文要点

This Prior Approval supplemental new drug application (sNDA) provides for the use of Fabhalta (iptacopan) tablets to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression and proposed modifications to the approved Fabhalta REMS.

批准信原文要点

This Prior Approval supplemental new drug application provides for the use of Fabhalta (iptacopan) for the treatment of adults with complement 3 glomerulopathy (C3G), to reduce proteinuria and proposed modification to the approved Fabhalta risk evaluation and mitigation strategy (REMS).

批准信原文要点

This “Prior Approval” sNDA provides for the use of Fabhalta (iptacopan) for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/g and proposed modifications to the approved Fabhalta REMS.

批准信原文要点

This Prior Approval sNDA provides for proposed modifications to the approved Fabhalta risk evaluation and mitigation strategy (REMS).

批准信原文要点

This supplemental new drug application provides for revisions to the labeling for Fabhalta, consistent with our February 14, 2024 letter.