FDA

Voyxact OK’d for primary IgA nephropathy

December 3, 2025

Brand name: Voyxact

Generic name: sibeprenlimab-szsi

Manufacturer: Otsuka Pharmaceutical Co.

Approval date: November 24, 2025

FDA granted accelerated approval to Voyxact (sibeprenlimab-szsi), a proliferation inducing ligand (APRIL) blocker, to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression.

Efficacy

Efficacy and safety of Voyxact were evaluated in the randomized, double-blind, placebo-controlled VISIONARY trial (NCT05248646) involving adults with biopsy-confirmed IgAN. The primary efficacy endpoint assessed the change from baseline in proteinuria (urine protein-to-creatinine ratio sampled from a 24-hour urine collection) after 9 months of treatment in the first 320 patients who had the opportunity to reach the month 9 visit. At 9 months, patients in the Voyxact group had a 50% reduction in proteinuria vs. a 2% increase in proteinuria in the placebo group.

Safety

Voyxact suppresses the immune system and may increase the risk of infections. Patients should be assessed for active infections before starting Voyxact and monitored for signs of infection during treatment. Voyxact may interfere with the immune response to vaccines and increase the risk of infection from live vaccines. Administration of live vaccines is not recommended within 30 days prior to starting Voyxact or during treatment with Voyxact.

The most common side effects of Voyxact are infections (including upper respiratory tract infection) and injection site reactions, including injection site erythema.

Recommended dose

The recommended dosage for Voyxact is 400 mg SC once every four weeks.

Sources:

FDA approves a new treatment for primary immunoglobulin A nephropathy. [News release]. 2025. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-new-treatment-primary-immunoglobulin-nephropathy

Voxact (sibeprenlimab-szsi) [package insert]. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761434s000lbl.pdf Revised November 2025. Accessed November 28, 2025.

Otsuka receives FDA accelerated approval for Voyxact® (sibeprenlimab-szsi) for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. [News release]. 2025. https://otsuka-us.com/news/otsuka-receives-fda-accelerated-approval-voyxactr-sibeprenlimab-szsi-reduction-proteinuria