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🏅 FDA Orphan Designation

Voyxact

sibeprenlimab

Manufacturer: Otsuka

Indicated for:
IgA NephropathyOrphanImmunoglobulin A nephropathyAccel.

FDA-Approved Indications (2)

IgA NephropathyOrphan Designation

Voyxact (sibeprenlimab) is a first-in-class APRIL inhibitor approved for reduction of proteinuria in adults with primary IgA nephropathy at risk for disease progression. It achieved a 51% placebo-adju

Immunoglobulin A nephropathyAccelerated Approval

indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression

Population: adults

Indications & Usage

1 INDICATIONS AND USAGE VOYXACT is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. This indication is approved under accelerated approval based on reduction of proteinuria. It has not been established whether VOYXACT slows kidney function decline over the long-term in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial. VOYXACT is an A Proliferation Inducing Ligand (APRIL) blocker, indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. ( 1 ) This indication is approved under accelerated approval based on reduction of proteinuria. It has not been established whether VOYXACT slows kidney function decline over the long-term in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial. ( 1 )

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Medical disclaimer: This information is for educational purposes only. Always consult a qualified healthcare provider before making treatment decisions. Data sourced from FDA and current as of our last update.