Otsuka Holdings Reports Positive Phase 3 Results for VOYXACT in IgA Nephropathy

TOKYO, Jul 02 (Pulse News Wire) – Otsuka Holdings CO.,LTD. (4578.T) announced positive results from the two-year phase 3 VISIONARY trial of VOYXACT® (siponimod) for treating adult patients with immunoglobulin A nephropathy (IgA nephropathy).

The study showed statistically significant improvements in estimated glomerular filtration rate (eGFR), indicating potential long-term renal protection and reduced risk of disease progression. The findings support siponimod's application for full approval from the US Food and Drug Administration (FDA) through a supplemental Biologics License Application (sBLA). Otsuka believes VOYXACT could drive future growth and enhance long-term enterprise value.

Detailed data will be submitted to regulatory authorities worldwide and presented at upcoming international conferences. "We are excited about the robust efficacy and safety profile demonstrated by siponimod," said John Kraus, Senior Vice President and Chief Medical Officer at OPDC. "This milestone underscores our commitment to advancing treatments for IgA nephropathy and improving patient outcomes.".