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PATIENTS AT RISK OF
DISEASE PROGRESSION

NEED NEW TREATMENT
STRATEGIES1,2

UNMET NEED

Across multiple large, diverse cohorts, most patients with IgA nephropathy progress to ESKD within their lifetime—even those previously considered low risk3-8

Diagnosis often occurs at CKD stage ≥3, when the risk of accelerated progression is already elevated8,9

UK RaDaR STUDY3

UK RaDaR STUDY3

54% 54%

In a retrospective study, 54% of patients with IgA nephropathy progressed to ESKD within 10 years, including patients with proteinuria <1 g/d*

*In the UK National Registry of Rare Kidney Diseases (RaDaR), a retrospective cohort of 2299 adults and 140 children with biopsy-confirmed IgA nephropathy with proteinuria >0.5 g/d or eGFR <60 mL/min/1.73 m2 at any time point in their clinical history was evaluated to assess disease progression. Data based on a subanalysis of 887 patients.

It has not been established whether VOYXACT has demonstrated a confirmed benefit in slowing kidney function decline in patients with IgA nephropathy.

US KAISER PERMANENTE STUDY8

Time-averaged proteinuria 0.5 to
<1 g/g was associated with

increased risk of experiencing
a ≥50%
decline in eGFR,
kidney failure, or death†

†In a real-world analysis of 655 patients with IgA nephropathy at Kaiser Permanente Southern California with a median follow-up time of 3.1 years (IQR 1.4–6.5). 70% were treated with RAAS inhibition and 41% were treated with immunosuppressants. The comparison group for calculation of risk was patients with time-averaged proteinuria <0.5 g/g.

CKD=chronic kidney disease; eGFR=estimated glomerular filtration rate; ESKD=end-stage kidney disease; IgA=immunoglobulin A; 
IQR=interquartile range; RaDaR=National Registry of Rare Kidney Diseases; RAAS=renin–angiotensin–aldosterone system.

KDIGO 2025 Guideline

Explore the recommended treatment considerations for IgA nephropathy

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Mechanism of Action

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targets APRIL

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APRIL=A PRoliferation-Inducing Ligand.

Efficacy

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APRIL=A PRoliferation-Inducing Ligand.

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  • References:

    1. Kidney Disease: Improving Global Outcomes (KDIGO) Glomerular Disease Work Group. Kidney Int. 2021;100(4S):S1-S276. doi: 10.1016/j.kint.2021.05.021
  • 2. Kidney Disease: Improving Global Outcomes (KDIGO) Nephrotic Syndrome In Children Work Group, Floege J, Gibson KL, et al. Kidney Int. 2025;107(5S):S241-S289.
  • 3. Pitcher D, et al. Clin J Am Soc Nephrol. 2023;18(6):727-738.
  • 4. Hastings MC, et al. Kidney Int Rep. 2018;3(1):99-104.
  • 5. Barbour S, et al. Kidney Int. 2013;84(5):1017-1024.
  • 6. Moriyama T, et al. PLoSOne. 2014;9(3):e91756.
  • 7. Le W, et al. Nephrol Dial Transplant. 2012;27(4):1479-1485.
  • 8. Sim JJ, et al. Nephrol Dial Transplant. 2025;40(11):2104-2117.
  • 9. Barratt J, et al. Front Med (Lausanne). 2024;11:1461879. doi:10.3389/fmed.2024.1461879
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