Otsuka Pharmaceutical Co., Ltd. and Otsuka Pharmaceutical Development & Commercialization, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of VOYXACT (sibeprenlimab-szsi). The therapy is indicated for reducing proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk of disease progression.
VOYXACT is a self-administered subcutaneous injection, dosed once every four weeks. The approval was based on interim results from the VISIONARY Phase 3 clinical trial, where VOYXACT demonstrated a significant placebo-adjusted treatment effect—achieving a 51% reduction in proteinuria at nine months of treatment (50% with VOYXACT vs. 2% with placebo, n=320).
Importantly, VOYXACT is the first and only therapy designed to block A-Proliferation-Inducing-Ligand (APRIL), representing a novel mechanism of action in the treatment of IgAN.
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Business News
June 19, 2026 16:46 ET Major central banks continued to dominate the economic news flow this week too, led by the Federal Reserve, as they announced their latest policy decisions. The Federal Reserve policy session was in focus as it was the first to be led by the new chief Kevin Warsh. In Europe, central banks of the U.K. and Switzerland announced their rate decisions. In Asia, the Bank of Japan drew attention for its policy moves, while data out of China threw some light on the state of the economy.