• 28 Nov 2025
• Admin
• News Article

FDA Grants Accelerated Approval to Voyxact for IgA Nephropathy

The FDA has granted accelerated approval for Voyxact (sibeprenlimab-szsi), a new therapy for adults with primary IgA nephropathy (IgAN) who are at risk of disease progression.
Voyxact is a self-administered injection taken once every four weeks.

This approval is based on interim results from the VISIONARY Phase 3 study, which showed a 51% placebo-adjusted reduction in proteinuria at nine months.

Why This Approval Matters?

Patients with IgAN often face a slow, irreversible decline in kidney function. Current therapies mostly offer supportive care rather than targeted intervention. Voyxact aims to change that.

What makes it different?

• Voyxact is the first and only therapy that blocks APRIL, a key driver in the IgAN disease pathway.
• It directly targets the root process that leads to accumulation of galactose-deficient IgA1 (Gd-IgA1).
• Its once-every-four-weeks dosing reduces treatment burden for patients.

Key Phase 3 Results (VISIONARY Interim Analysis)

Efficacy

At nine months (n=320):

• Voyxact: ~50% reduction in proteinuria
• Placebo: ~2% reduction
• Placebo-adjusted effect: 51% (P<0.0001)

Proteinuria reduction is a validated surrogate marker linked to delayed kidney failure.

Safety

Most side effects were mild or moderate. Common reactions (≥10%):

• Infections: 49% (Voyxact) vs 45% (placebo)
• Injection site reactions: 24% vs 23%
• Most infections were upper respiratory (15% vs 14%).
• Most injection site events were mild erythema (13% vs 12%).

How Voyxact Works?

Voyxact blocks APRIL, a protein that drives IgAN through the “4-hit” mechanism.
APRIL promotes excessive Gd-IgA1 production, which forms harmful immune complexes in the kidneys. Blocking APRIL reduces circulating Gd-IgA1 and may help stabilize disease activity.

Expert Reactions

John Kraus, CMO, Otsuka:

“With its targeted mechanism, strong efficacy, safety profile, and once-every-four-weeks dosing, Voyxact offers a new option for IgAN patients.”

Dr. Dana Rizk, University of Alabama at Birmingham:

“Voyxact is the first approved IgAN treatment that blocks APRIL. Its potential impact is encouraging.”

IgA Nephropathy Foundation:

“This approval gives patients new hope. More options are urgently needed.”

About the VISIONARY Phase 3 Study

• Design: Randomized, double-blind, placebo-controlled
• Patients: 510 adults with biopsy-confirmed IgAN
• Standard therapy: ACEi or ARB (± SGLT2 inhibitor)
• Intervention: Voyxact 400 mg every four weeks
• Primary endpoint: uPCR ratio at month nine
• Ongoing endpoint: eGFR slope at 24 months
• eGFR data expected: Early 2026

This data will determine whether Voyxact secures full FDA approval.

Understanding the Disease

IgA nephropathy is a chronic immune-mediated kidney disorder. It usually affects adults aged 20–40 and can lead to end-stage kidney disease over time.

Key facts:

• Caused by buildup of pathogenic Gd-IgA1 in the kidneys
• Leads to chronic inflammation and progressive loss of kidney function
• Supportive care slows decline but does not address root cause

There remains a significant unmet need for disease-modifying therapies