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GAIN GREATER
INSIGHT
INTO THE
CLINICAL DATA

WITH EXPLORATORY
ENDPOINTS

VISIONARY interim analysis:
Spot uPCR over time

Percent change from baseline in spot uPCR over 12 months graph Percent change from baseline in spot uPCR over 12 months graph
Percent change from baseline in spot uPCR over 12 months graph Percent change from baseline in spot uPCR over 12 months graph

VISIONARY interim analysis:
Spot uPCR over time

*The dots indicate the geometric mean percentage change at specific weeks compared with baseline and the whiskers indicate the corresponding 95% CIs based on observed and non-imputed spot uPCR.

CI=confidence interval; uPCR=urine protein-creatinine ratio.

Data were exploratory and not adjusted for multiplicity. The results should be interpreted with caution and could represent chance findings.

VISIONARY interim analysis:
uPCR-24h (g/g) at 12 months1,2

  • 54.3% placebo-adjusted treatment effect (95% CI, 46.4%-60.9%)
uPCR-24h at month 12 compared to baseline graph uPCR-24h at month 12 compared to baseline graph
uPCR-24h at month 12 compared to baseline graph uPCR-24h at month 12 compared to baseline graph

VISIONARY interim analysis:
uPCR-24h (g/g) at 12 months1,2

  • 54.3% placebo-adjusted treatment effect 
    (95% CI, 46.4%-60.9%)

† This analysis was performed on patients in the interim analysis set who had a baseline uPCR measured from at least one 24-hour urine sample and was assessed using mixed model for repeated measures.

‡ Number of patients with baseline and visit-specific uPCR-24h.

CI=confidence interval; uPCR=urine protein-creatinine ratio.

Data were exploratory and not adjusted for multiplicity. The results should be interpreted with caution and could represent chance findings.

VISIONARY interim analysis:
Proteinuria <0.5 g/d at Month 121

Proteinuric remission at month 12 graph Proteinuric remission at month 12 graph
Proteinuric remission at month 12 graph Proteinuric remission at month 12 graph

VISIONARY interim analysis:
Proteinuria <0.5 g/d at Month 121

§ This analysis was performed on participants in the interim analysis set who had a baseline uPCR measured from at least one 24-hour urine sample.

‖ Number of participants with urine total protein <0.5 g/day at Month 12.

Number of participants with nonmissing urine total protein at Month 12.

CI=confidence interval; uPCR=urine protein-creatinine ratio.

Data were exploratory and not adjusted for multiplicity. The results should be interpreted with caution and could represent chance findings.

VISIONARY interim analysis:
Change in Positive Dipstick Hematuria1

Change in positive dipstick hematuria over time graph Change in positive dipstick hematuria over time graph
Change in positive dipstick hematuria over time graph Change in positive dipstick hematuria over time graph

VISIONARY interim analysis:
Change in Positive Dipstick Hematuria1

Hematuria (1+, 2+, 3+, and trace) at baseline vs Week 48 n (%) VOYXACT Baseline 119 (78.3) Week 48 22 (19.8) Placebo 119 (70.8) 89 (69.0)
n (%) Baseline Week 48 VOYXACT Placebo Hematuria (1+, 2+, 3+, and trace) at baseline vs Week 48 119 (78.3) 22 (19.8)% 119 (70.8) 89 (69.0)

Data were exploratory and not adjusted for multiplicity. The results should be interpreted with caution and could represent chance findings.

# This analysis was performed on participants in the interim analysis set who had a baseline uPCR measured from at least one 24-hour urine sample.

uPCR=urine protein-creatinine ratio.

Data were exploratory and not adjusted for multiplicity. The results should be interpreted with caution and could represent chance findings.

PHARMACODYNAMICS

APRIL and Gd-IgA1 levels decreased within 4 weeks
of the first dose of VOYXACT® (sibeprenlimab-szsi)

Change in APRIL level over 48 weeks Change in APRIL level over 48 weeks
Change in APRIL level over 48 weeks Change in APRIL level over 48 weeks
>90% suppression of APRIL
>90% suppression of APRIL

Suppression seen as early as Week 4 and sustained throughout treatment

Data were exploratory and not adjusted for multiplicity. The results should be interpreted with caution and could represent chance findings.

**This analysis was performed on all randomized patients who received at least 1 dose of sibeprenlimab-szsi and had a baseline and at least 1 post-baseline evaluable PD measurement (data cutoff September 4, 2024).

APRIL=A PRoliferation-inducing Ligand; CI=confidence interval; PD=pharmacodynamics.

Change in Gd-IgA1 level over 48 weeks Change in Gd-IgA1 level over 48 weeks
Change in Gd-IgA1 level over 48 weeks Change in Gd-IgA1 level over 48 weeks
67% mean reduction from baseline in Gd-IgA1 at 48 weeks
67% mean reduction from baseline in Gd-IgA1 at 48 weeks

Reduction seen as early as Week 4 and reached a plateau by Week 24

A 69% reduction in IgA, 35% reduction in IgG, and 75% reduction in IgM were observed at 48 weeks

Data were exploratory and not adjusted for multiplicity. The results should be interpreted with caution and could represent chance findings.

††This analysis was performed on all randomized patients who received at least 1 dose of sibeprenlimab-szsi and had a baseline and at least 1 post-baseline evaluable PD measurement (data cutoff September 4, 2024).

CI=confidence interval; Gd-IgA1=galactose-deficient IgA1; IgA=immunoglobulin A; IgG=immunoglobulin G; IgM=immunoglobulin M; PD=pharmacodynamics.

Mechanism of Action

See how VOYXACT 
targets APRIL

View the MOA

APRIL=A PRoliferation-Inducing Ligand.

Dosing

Explore the recommended dosing and administration

Explore Dosing

Patient Support

Discover available resources for your patients

Learn More

APRIL=A PRoliferation-Inducing Ligand.

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  • References:

    1. Perkovic V, et al. N Engl J Med. 2026;394:635-646.
  • 2. Data on file. SIBE-022. Otsuka America Pharmaceutical, Inc.; Rockville, MD.
ISI Block Title

INDICATION and IMPORTANT SAFETY INFORMATION for VOYXACT® (sibeprenlimab-szsi)

INDICATION

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.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATION

VOYXACT is contraindicated in patients with serious hypersensitivity to sibeprenlimab-szsi or any of the excipients of VOYXACT.

WARNINGS AND PRECAUTIONS

Immunosuppression and Increased Risk of Infections: VOYXACT suppresses the immune system by reducing antibody production, which may increase the risk of infections. Patients with chronic or recurring infections may have an increased risk of serious infection. In clinical trials, infections occurred in 49% of patients treated with VOYXACT compared with 45% of patients treated with placebo.

Before initiating VOYXACT, assess patients for active infections. During treatment, monitor patients for signs and symptoms of infection. If a serious infection develops, consider interrupting VOYXACT until the infection is controlled.

Immunosuppression and Immunization Risks: Because of its mechanism of action, VOYXACT may interfere with immune responses to vaccines and increase the risk of infection from live vaccines. Live vaccines are not recommended within 30 days prior to initiation of VOYXACT or during treatment with VOYXACT as safety has not been established. No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving VOYXACT or on the efficacy of immunizations administered while receiving VOYXACT.

Common Adverse Reactions: The most common adverse reactions (reported in ≥10% of patients treated with VOYXACT and at a higher incidence than placebo) in patients treated with VOYXACT and placebo, respectively, were infections (49% versus 45%) and injection site reactions (24% versus 23%). The most common infection was upper respiratory infection (15% versus 14%), and the most common injection site reaction was injection site erythema (13% versus 12%). Most adverse reactions were reported as mild or moderate in severity and resolved without treatment interruption or discontinuation.

Pregnancy: There are no available data on VOYXACT use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Monoclonal antibodies, such as sibeprenlimab-szsi, can be actively transported across the placenta as pregnancy progresses; therefore, potential effects on a fetus are likely to be greater during the second and third trimester of pregnancy.

Lactation: There are no data on the presence of sibeprenlimab-szsi in human milk, the effects of sibeprenlimab-szsi on the breastfed infant, or the effects of sibeprenlimab-szsi on milk production.

Pediatric Use: Safety and effectiveness of VOYXACT in pediatric patients have not been established.

Geriatric Use: Clinical studies of VOYXACT did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger adult patients.

Pregnant women exposed to VOYXACT, or their healthcare providers, should report VOYXACT exposure by calling 1-833-869-9228 or visiting 
www.VOYXACT.com

To report SUSPECTED ADVERSE REACTIONS, contact Otsuka America Pharmaceutical, Inc. at 1-800-438-9927 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch).

Please see FULL PRESCRIBING INFORMATION.

Important Safety Information
ISI Block Title

INDICATION and IMPORTANT SAFETY INFORMATION for VOYXACT® (sibeprenlimab-szsi)

INDICATION

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.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATION

VOYXACT is contraindicated in patients with serious hypersensitivity to sibeprenlimab-szsi or any of the excipients of VOYXACT.

WARNINGS AND PRECAUTIONS

Immunosuppression and Increased Risk of Infections: VOYXACT suppresses the immune system by reducing antibody production, which may increase the risk of infections. Patients with chronic or recurring infections may have an increased risk of serious infection. In clinical trials, infections occurred in 49% of patients treated with VOYXACT compared with 45% of patients treated with placebo.

Before initiating VOYXACT, assess patients for active infections. During treatment, monitor patients for signs and symptoms of infection. If a serious infection develops, consider interrupting VOYXACT until the infection is controlled.

Immunosuppression and Immunization Risks: Because of its mechanism of action, VOYXACT may interfere with immune responses to vaccines and increase the risk of infection from live vaccines. Live vaccines are not recommended within 30 days prior to initiation of VOYXACT or during treatment with VOYXACT as safety has not been established. No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving VOYXACT or on the efficacy of immunizations administered while receiving VOYXACT.

Common Adverse Reactions: The most common adverse reactions (reported in ≥10% of patients treated with VOYXACT and at a higher incidence than placebo) in patients treated with VOYXACT and placebo, respectively, were infections (49% versus 45%) and injection site reactions (24% versus 23%). The most common infection was upper respiratory infection (15% versus 14%), and the most common injection site reaction was injection site erythema (13% versus 12%). Most adverse reactions were reported as mild or moderate in severity and resolved without treatment interruption or discontinuation.

Pregnancy: There are no available data on VOYXACT use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Monoclonal antibodies, such as sibeprenlimab-szsi, can be actively transported across the placenta as pregnancy progresses; therefore, potential effects on a fetus are likely to be greater during the second and third trimester of pregnancy.

Lactation: There are no data on the presence of sibeprenlimab-szsi in human milk, the effects of sibeprenlimab-szsi on the breastfed infant, or the effects of sibeprenlimab-szsi on milk production.

Pediatric Use: Safety and effectiveness of VOYXACT in pediatric patients have not been established.

Geriatric Use: Clinical studies of VOYXACT did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger adult patients.

Pregnant women exposed to VOYXACT, or their healthcare providers, should report VOYXACT exposure by calling 1-833-869-9228 or visiting 
www.VOYXACT.com

To report SUSPECTED ADVERSE REACTIONS, contact Otsuka America Pharmaceutical, Inc. at 1-800-438-9927 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch).

Please see FULL PRESCRIBING INFORMATION.

Click or scroll to see FULL IMPORTANT SAFETY INFORMATION AND INDICATION