Otsuka Pharmaceutical：VoyxactSibeprenlimab was approved through the priority review process.
The National Medical Products Administration (NMPA) recently granted conditional approval to Otsuka Pharmaceutical Co., Ltd. for Sibeprenlimab Injection (subcutaneous injection) (brand name: Voyxact) through a priority review and approval process. The drug is indicated for reducing proteinuria in adult patients with primary immunoglobulin A nephropathy (IgAN) who are at risk of disease progression. The approval of this product provides a new treatment option for relevant patients.
Voyxact, approved in China for maintaining renal function in adult patients with primary IgA nephropathy, is the world’s first APRIL-targeting monoclonal antibody approved for marketing. The drug was originally developed by Vistera and acquired by Otsuka Pharmaceutical in 2018 for $430 million. Its mechanism precisely targets the core pathway of IgA nephropathy: by selectively binding and inhibiting APRIL activity, it reduces levels of pathogenic IgA and galactose-deficient Gd-IgA1, thereby delaying the progression of end-stage renal disease. The dosing regimen is convenient—subcutaneous injection once every four weeks, which can be self-administered at home.
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