Otsuka's VOYXACT gains accelerated FDA approval for IgA nephropathy

Otsuka Holdings announced on November 25, 2025, that its wholly-owned subsidiary, Otsuka Pharmaceutical, along with Otsuka Pharmaceutical Development & Commercialization, Inc., received accelerated approval from the U.S. FDA for VOYXACT (sibeprenlimab). The drug is indicated for "reducing proteinuria in adults with IgA nephropathy at risk of progression." This approval was based on priority review.

The Phase 3 VISIONARY trial interim analysis showed VOYXACT significantly reduced uPCR (urinary protein-to-creatinine ratio) by 51.2% (P<0.0001) compared to placebo after nine months of treatment, with a favorable safety profile. VOYXACT, the first and only APRIL-targeting therapy, works by selectively inhibiting APRIL's action, reducing pathogenic galactose-deficient IgA1 (Gd-IgA1), which directly correlates with proteinuria improvement. Proteinuria reduction serves as a surrogate endpoint correlating with delayed kidney function decline, supporting accelerated approval.

VOYXACT is a pre-filled syringe formulation for subcutaneous self-administration, offering the convenience of at-home dosing every four weeks. IgA nephropathy is a progressive autoimmune chronic kidney disease, often leading to end-stage renal disease. Data on eGFR from the VISIONARY study, which will determine long-term benefits and support continued approval, are expected in early 2026.