FDA Accelerates Approval of VOYXACT for IgA Nephropathy: A New Horizon in Treatment

VOYXACT (sibeprenlimab-szsi) received FDA accelerated approval to reduce proteinuria in adults with primary IgA nephropathy, the company reported in a press release.

An interim Phase 3 analysis, per the sponsor, showed a placebo‑adjusted ~51% reduction in proteinuria at nine months; these interim results formed the basis for the accelerated approval, which remains contingent on confirmatory outcomes data. The approval is described as applying to adults with primary IgA nephropathy who have persistent proteinuria.

The press release states that a confirmatory outcomes program is ongoing, including the VISIONARY study, which the sponsor describes as the trial intended to assess the longer‑term renal outcomes required to convert accelerated approval into regular approval. Details on timing and prespecified renal endpoints are provided by the sponsor as the foundation of the confirmatory plan.

In summary, the regulatory action provides provisional access based on a surrogate endpoint reported by the sponsor. Interpretation of these interim findings depends on forthcoming confirmatory outcomes; regulatory labeling and detailed study reports will inform prescribing and coverage decisions as they become available.