NOW FDA
APPROVED

VOYXACT® (sibeprenlimab-szsi) is
the first and only APRIL blocker for
IgA nephropathy

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.

Read the Press Release

APRIL=A PRoliferation-Inducing Ligand;
IgA=immunoglobulin A.

FIRST AND ONLY APRIL BLOCKER

VOYXACT binds to APRIL, blocking signaling at the BCMA
and TACI receptors.

Inhibition of APRIL results in reduced levels of Gd-IgA1,
which is implicated in the pathogenesis of IgA nephropathy.

BCMA=B-cell maturation antigen; Gd-IgA1=galactose-deficient IgA1; TACI=transmembrane
activator and calcium modulator and cyclophilin ligand interactor.

SIGNIFICANT PROTEINURIA REDUCTION

VISIONARY Study Design

VISIONARY is a randomized, double-blind, placebo-controlled study of 510 adults with biopsy-confirmed IgA nephropathy, an eGFR ≥30 mL/min/1.73 m², and proteinuria (defined as either uPCR based on 24-hour urine collections ≥0.75 g/g or urine protein ≥1.0 g/day)
Patients were randomized 1:1 to receive VOYXACT (n=259) or placebo (n=251) subcutaneously every 4 weeks and remained on a stable and maximally tolerated dose of ACE inhibitors and/or ARBs with or without an SGLT2 inhibitor throughout the study
An interim analysis for efficacy was conducted on the first 320 randomized patients who reached the Month 9 visit (VOYXACT, n=152; placebo, n=168)

Primary Endpoint: Relative Change From
Baseline in uPCR-24h at Month 9*

*Estimated geometric mean percentage change at 9 months compared with baseline. Data were included in the analysis regardless of early treatment discontinuation and initiation of confounding therapy (treatment policy strategy). Missing data were imputed using multiple imputation.

^†96.5% CI corresponds to the two-sided significance level of 0.035 for the interim analysis.

ACE=angiotensin-converting enzyme; ARB=angiotensin receptor blocker; CI=confidence interval; eGFR=estimated glomerular filtration rate; SGLT2=sodium-glucose cotransporter 2; uPCR=urine protein-creatinine ratio.

The treatment effect (percentage reduction in uPCR-24h between VOYXACT and placebo) was consistent across key subgroups and prespecified stratification factors of baseline proteinuria (uPCR-24h), baseline eGFR, and SGLT2 inhibitor use.

VISIONARY STUDY SAFETY PROFILE

Adverse Reactions in ≥10%
of Patients Treated With
VOYXACT and at a Higher
Incidence Than Placebo

Most adverse reactions were reported as mild or moderate in severity and resolved without treatment interruption or discontinuation

VOYXACT suppresses the immune system by reducing
antibody production, which may increase the risk of infections.

EXPLORATORY ENDPOINT¹PERCENT CHANGE FROM BASELINE IN SPOT uPCR (g/g) OVER TIME^‡§

Reductions in Spot uPCR

^‡The observed mean percent change from baseline over time for uPCR spot first morning
void samples. 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.

^§ Mean change in spot uPCR from baseline was an unranked exploratory endpoint. Results
cannot be considered statistically significant.

EXPLORATORY ENDPOINT¹EVALUATION OF APRIL AND Gd-IgA1 CONCENTRATIONS OVER TIME

Decreased Levels of
APRIL and Gd-IgA1^∥

^∥Reductions in APRIL and Gd-IgA1 were
exploratory endpoints and were not controlled
for multiplicity. Results cannot be considered
statistically significant.

SELF-ADMINISTERED DOSING

VOYXACT is a 400 mg/2 mL
subcutaneous injection dosed
once
every 4 weeks. Single-dose prefilled
syringes can
be self-administered or
administered by a caregiver.

PATIENT SERVICES

PRESCRIPTION SAVINGS
AND COVERAGE

VOYXACT Copay Program: Eligible patients
with commercial insurance may pay as little as
$0 for a prescription of VOYXACT*
*Terms and conditions apply.
VOYXACT Bridge Program: If a patient has
challenges with insurance coverage for VOYXACT,
the Bridge Program offers temporary access, so your
patient isn’t delayed in starting their treatment^†
^†Eligibility required.

SPECIALTY PHARMACY SUPPORT

Once you submit a prescription for VOYXACT, the specialty
pharmacy PANTHERx Rare will contact your patient directly
and coordinate delivery.

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Reference: 1. Data on file. SIBE-023. Otsuka
America Pharmaceutical, Inc.; Rockville, MD.

NOW FDA
APPROVED

FIRST AND ONLY APRIL BLOCKER