Otsuka Receives Approval for VOYXACT for Reducing Proteinuria in IgA Nephropathy
Thursday, November 27, 2025
Otsuka Pharmaceutical has received accelerated approval from the U.S. Food and Drug Administration (FDA) for VOYXACT® (sibeprenlimab-szsi) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk of disease progression.
IgA nephropathy is a chronic, immune-mediated kidney disorder that usually develops in early adulthood and can lead to end-stage kidney disease. Despite supportive therapies, many patients continue to experience disease progression, highlighting the need for treatments that address underlying mechanisms.
VOYXACT was originally designed and developed by Visterra, an Otsuka subsidiary, and is a humanised monoclonal antibody that blocks APRIL to reduce the production of harmful galactose-deficient IgA1.
Proteinuria reduction is recognised as a surrogate indicator for delaying the progression of kidney disease and is often used to support accelerated approvals in IgAN trials. However, it has not yet been confirmed whether VOYXACT slows long-term kidney function decline.
The treatment is administered subcutaneously once every four weeks.
The approval is based on interim results from the Phase 3 VISIONARY study, where VOYXACT showed a 51% placebo-adjusted reduction in proteinuria at nine months. This outcome supports its role as a targeted therapy that blocks APRIL, a key driver in the biological process leading to IgAN. VOYXACT is currently the only approved therapy that blocks this pathway.
In clinical testing, APRIL inhibition led to a reduction in galactose-deficient IgA1, a key factor in the development and progression of IgAN.
The VISIONARY trial enrolled 510 adults with biopsy-confirmed IgAN who were already receiving supportive therapy, including ACE inhibitors, ARBs and, in some cases, SGLT2 inhibitors. Participants were randomised to receive VOYXACT or placebo every four weeks while continuing their existing treatment. The primary measurement was the change in 24-hour urine protein-to-creatinine ratio at nine months.
The treatment offers a targeted approach for patients who continue to face limited options despite supportive care.
Source: businesswire.com
