Reduces proteinuria. BLA 761434, held by Otsuka Pharm Co Ltd. Sibeprenlimab-Szsi.
As of Nov 13, 2026, BLA 761434 (Voyxact), held by Otsuka Pharm Co Ltd, was first approved by FDA on Nov 25, 2025, with 0 approved supplements and 0 published complete response letters.
VOYXACT is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. This indication is approved under accelerated approval based on reduction of proteinuria. It has not been established whether VOYXACT slows kidney function decline over the long-term in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 25, 2025 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Voyxact400MG/2ML(200MG/ML) · injectable;injection | Sibeprenlimab-Szsi | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
