• 01 Dec 2025
• Admin
• News Article

FDA Grants Accelerated Approval to Otsuka’s VOYXACT for IgA Nephropathy

Otsuka Pharmaceutical has secured accelerated FDA approval for VOYXACT® (sibeprenlimab-szsi), a first-in-class therapy designed to reduce proteinuria in adults with primary IgA nephropathy (IgAN) who are at risk of disease progression.

This marks a significant step forward for a condition where treatment options remain limited.

Why IgA Nephropathy Needs Better Treatments?

IgA nephropathy is a chronic immune-mediated kidney disease that often begins in early adulthood. Many patients eventually progress to end-stage kidney disease despite standard therapies like ACE inhibitors, ARBs, and SGLT2 inhibitors.

Proteinuria remains one of the strongest indicators of future kidney decline. Reducing it early can shift long-term outcomes.

What Makes VOYXACT Different?

VOYXACT was developed by Visterra, an Otsuka subsidiary. It is a humanised monoclonal antibody that blocks APRIL, a key protein that drives the production of harmful galactose-deficient IgA1.

Key features:

• Targets the root biology of IgAN
• Blocks APRIL, a unique mechanism not addressed by current therapies
• Once-every-four-weeks subcutaneous dosing
• Only approved therapy targeting the APRIL pathway

While VOYXACT reduces proteinuria, it is still unknown whether it slows long-term kidney function loss. Further confirmatory trials are required.

What the Clinical Data Shows?

The approval is based on interim results from the Phase 3 VISIONARY trial.

Highlights from the study:

• 51% placebo-adjusted proteinuria reduction at nine months
• Reduction in disease-driving galactose-deficient IgA1
• Total of 510 adults enrolled with biopsy-confirmed IgAN
• Participants continued standard therapy (ACEi/ARB ± SGLT2i)
• Dosing: VOYXACT vs placebo every four weeks
• Primary endpoint: change in 24-hour urine protein-to-creatinine ratio

These findings support VOYXACT as a targeted therapy for patients who continue to progress despite standard care.

Why This Approval Matters?

IgAN patients often face:

• Slow but steady kidney decline
• Limited treatment options
• Few therapies that address underlying biological drivers

VOYXACT introduces a pathway-specific approach that may change the standard of care for high-risk patients.