The FDA has granted accelerated approval to a new treatment option for adults with primary IgA nephropathy (IgAN) who are at risk for disease progression. The medication, called VOYXACT (sibeprenlimab-szsi), is given as a self-administered injection every 4 weeks and is designed to reduce proteinuria, one of the most important markers of IgAN progression. While this medication shows promising early results, researchers are still studying whether it slows long-term kidney function loss. *

Here’s what patients and caregivers should know.

What This New Approval Means

The FDA granted accelerated approval based on results from the VISIONARY Phase 3 interim analysis, which showed:

• 51% placebo-adjusted reduction in proteinuria after 9 months
  • Patients on VOYXACT saw a 50% drop
  • Patients on placebo saw 2%
• The study included 320 adults already on standard IgAN care (ACE inhibitor/ARB with or without SGLT2 inhibitor).

Because the approval is based on proteinuria reduction, a surrogate marker for slowing kidney disease, full approval will require confirmation from the ongoing clinical trial evaluating long-term kidney outcomes (eGFR decline). Those results are expected in 2026.

How VOYXACT Works

VOYXACT targets a molecule called APRIL, which plays a key role in producing galactose-deficient IgA1 (Gd-IgA1), the harmful form of IgA involved in IgAN.

By blocking APRIL, VOYXACT:

• lowers levels of Gd-IgA1
• interrupts part of the “4-hit” process believed to contribute to IgAN
• helps reduce inflammation and protein leakage in the kidneys

Experts believe this type of targeted therapy represents a meaningful shift toward addressing the root causes of IgAN rather than managing symptoms alone.

“VOYXACT represents a novel targeted approach for IgAN,” said Dr. John Kraus of Otsuka.

What the Study Found

Effectiveness

In the interim analysis:

• Proteinuria dropped by 50% on VOYXACT
• There was a 51% advantage over placebo
• Patients continued their background therapies throughout the study

Proteinuria reduction is strongly linked to better long-term kidney outcomes in IgAN, which is why it is used for accelerated approvals.

Safety

Most side effects were mild to moderate and similar to the placebo group. Most common reactions:

• Infections: 49% (vs 45% on placebo)
• Injection-site reactions: 24% (vs 23% on placebo)
• Upper respiratory infections were the most common infection reported.

Because VOYXACT affects the immune system by lowering antibody production, patients must be monitored for infections and avoid live vaccines before or during treatment.

Who Might Be Eligible

VOYXACT is approved for adults with primary IgA nephropathy at risk for disease progression, meaning patients who typically have:

• Confirmed IgAN by kidney biopsy
• Elevated urine protein levels (≥0.75–1.0 g/day)
• eGFR ≥ 30 mL/min/1.73m²
• Ongoing supportive therapy (ACEi/ARB ± SGLT2 inhibitor)

Your nephrologist will determine whether VOYXACT is appropriate based on your kidney function, proteinuria levels, medical history, and infection risk.

Important Safety Notes

Patients should talk with their clinician about:

• Infection risk: The medication reduces antibody production.
• Vaccines: Live vaccines should be avoided before and during treatment.
• Allergic reactions: VOYXACT should not be used in people who have had serious hypersensitivity reactions to the drug.
• Pregnancy & breastfeeding: There is no data yet on safety for pregnant or breastfeeding individuals.
• Pediatric use: Not yet studied in children.
  

Why This Matters for People Living With IgAN

IgA nephropathy often affects young adults and can slowly worsen over many years, eventually leading to kidney failure in many patients. While supportive medications (ACE inhibitors, ARBs, SGLT2 inhibitors) help, many people need additional treatment to better control proteinuria.

VOYXACT adds another targeted, biologic therapy to the growing list of IgAN options — and is the first therapy to block APRIL.

“This approval offers hope for IgAN patients who need new treatment options,” said Dr. Dana Rizk, investigator in the VISIONARY trial.

Patient advocates also expressed optimism, highlighting the urgent need for therapies that address the underlying biology of IgAN.

The Bottom Line

VOYXACT is a newly FDA-approved treatment that offers promising proteinuria reduction for adults with primary IgAN at risk for progression. However, its long-term effect on kidney function is still being studied.

If you’re living with IgAN, consider asking your care team:

• Whether you meet the criteria for VOYXACT
• How this therapy fits with your current treatment plan
• What risks and benefits to expect
• Whether participation in ongoing studies is an option
  

We’ll continue to share updates as the VISIONARY trial releases more data in 2026.

* Business Wire (November 26, 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”. businesswire.com

To ensure that we always provide you with high-quality, reliable information, Responsum Health closely vets all sources. We do not, however, endorse or recommend any specific providers, treatments, or products, and the use of a given source does not imply an endorsement of any provider, treatment, medication, procedure, or device discussed within.