Not an
actual patient.

The VOYXACT® Impact

A significant reduction of protein in your urine.

VOYXACT reduced proteinuria by 50% vs
a 2% increase
with placebo at 9 months.

Change in proteinuria at 9 months of treatment (n = 320).*

Efficacy Results

The results in this graph are based on an analysis of the first 320 adults in the trial at 9 months. This study is ongoing. These results were consistent across sex, age, race, ethnicity, and geographic region. At the beginning of the trial, participants had a mean uPCR-24h of 1.5 g/g.

VOYXACT was studied in adults with primary IgA nephropathy who are at risk for their disease getting worse.

Patient Population icon

510 adults with IgA nephropathy were studied in the VISIONARY clinical trial, all with reduced kidney function and protein in their urine.

ACE Inhibitors and ARBs icon

Adults were randomly assigned into 2 groups—about half received an injection of VOYXACT, and about half received a placebo injection
(no active medicine).

Blood Pressure icon

Almost all participants (98%) were also receiving the maximum tolerated dose of blood pressure medications (ACE inhibitors and/or ARBs).

Blood sugar-lowering medications icon

Many (40%) were also taking 
blood sugar–lowering medications (SGLT2 inhibitors).

IgA=immunoglobulin A.
ACE inhibitors=angiotensin-converting enzyme inhibitors.
ARBs=angiotensin receptor blockers.
SGLT2 inhibitors=sodium-glucose cotransporter 2 inhibitors.

Side effects for people taking VOYXACT were similar to those on placebo.

The safety of VOYXACT was evaluated in 510 patients with IgA nephropathy.

VISIONARY Trial Side Effects Chart
Response icon Response icon

Most infections and injection-site reactions were mild to moderate and resolved without pausing or stopping treatment.

Doctor icon Doctor icon

Tell your doctor if you develop signs and symptoms of an infection.

Not an actual patient.

See why lowering proteinuria levels
is so important
when you live with
IgA nephropathy.

Understanding proteinuria
INDICATION and IMPORTANT SAFETY INFORMATION for VOYXACT® (sibeprenlimab‑szsi)

INDICATION

VOYXACT is a prescription medicine used to reduce protein in the urine (proteinuria) in adults with a kidney disease called primary immunoglobulin A nephropathy (IgAN) who are at risk for their disease getting worse. It is not known if VOYXACT is safe and effective in children.

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

What is the most important information I should know about VOYXACT?

  • Do not take VOYXACT if you are allergic to any of the ingredients in VOYXACT. Stop using VOYXACT and get emergency help if you develop signs and symptoms of an allergic reaction, including:
    • breathing problems
    • swelling of the face, lips, mouth, tongue or throat
    • dizziness or feel lightheaded
    • itching
    • hives
    • skin rash

Before taking VOYXACT, tell your healthcare provider about all of your medical conditions, including if you:

  • have an infection.
  • have received or plan to receive therapy that can lower the ability of your immune system to fight infections (immunosuppressive therapy).
  • have recently received or are scheduled to receive an immunization (vaccine). VOYXACT may affect your immune system response to vaccines and increase your risk of infections from live vaccines.
  • are pregnant or plan to become pregnant. It is not known if VOYXACT will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if VOYXACT passes into your breast milk or if it will affect your baby. Talk to your healthcare provider about the best way to feed your baby during treatment with VOYXACT.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I take VOYXACT?

  • Read the detailed “Instructions for Use” that come with VOYXACT for information about how to prepare and inject VOYXACT, and how to properly store and throw away (dispose of) used VOYXACT prefilled syringes.
  • Use VOYXACT exactly as your healthcare provider tells you to.
  • If you miss a dose of VOYXACT, inject the missed dose as soon as possible. Then take your next dose in 4 weeks.

What are the possible side effects of VOYXACT?

VOYXACT can cause serious side effects, including: 

  • immunosuppression and increased risk of infections. VOYXACT weakens your immune system, which may increase your risk of infections. Your healthcare provider will check you for signs and symptoms of infections before you start and during treatment with VOYXACT. Tell your healthcare provider right away if you develop any signs and symptoms of infection during treatment with VOYXACT, including:
    • fever
    • chills
    • feeling tired
    • cough
    • flu-like symptoms
    • aches and pain
    • warm, red, or painful skin

The most common side effects of VOYXACT include: upper respiratory tract infection and skin redness at your injection site.

These are not all of the possible side effects of VOYXACT. 

Call your doctor for medical advice about side effects.
You are encouraged to report side effects to FDA. 
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see FULL PRESCRIBING INFORMATION 
and PATIENT INFORMATION.