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FDA Accelerated Approval: Vanrafia® (atrasentan) has been approved for reducing proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression.

Phase III ALIGN Study: Approval is based on interim data from a clinical trial showing proteinuria reduction at 36 weeks. Full results, including kidney function impact, are expected in 2026.

Novartis Expands Kidney Disease Portfolio: This marks the third FDA approval in the past year, following Fabhalta®'s approvals for C3 glomerulopathy and IgAN.

Novartis has announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Vanrafia® (atrasentan), a potent and selective endothelin A (ETA) receptor antagonist, for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) who are at high risk of rapid disease progression. The approval is based on interim results from the Phase III ALIGN study, which demonstrated a significant reduction in urine protein-to-creatinine ratio (UPCR) at 36 weeks compared to placebo.

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