IgA nephropathy (IgAN) is a kidney disorder caused by a buildup of immune complexes and the antibody called immunoglobulin A (IgA) inside the kidneys. This buildup causes inflammation in the kidneys. The inflammation causes damage to the filtering unit (glomerulus) inside the kidneys, affecting how blood is filtered in its small blood vessels. Some people with IgA nephropathy have no symptoms, while others have symptoms such as blood in their urine.
Protein in the urine (proteinuria) can also be a sign of kidney damage. When the kidneys are healthy, they usually keep protein in the blood. In people with IgA nephropathy, the kidneys can become inflamed and damaged, which allows protein to leak into the urine.
IgA nephropathy is a progressive disease. That means it gets worse over time. It is not curable, but treatments can slow kidney damage. Voyxact (sibeprenlimab-szsi) is a prescription medicine used to reduce protein in the urine in adults with primary IgAN who are at risk for their disease getting worse.
How Does Voyxact Work for IgA Nephropathy?
Voyxact works by helping to lower the levels of the IgA antibody.
Voyxact binds to a protein called APRIL and blocks its signaling. APRIL stands for “a proliferation-inducing ligand.” It is a type of signaling protein that belongs to the tumor necrosis factor (TNF) family, a group of proteins that help control how cells grow, survive, and die. Cells use proteins like APRIL to send messages to each other. APRIL helps certain immune cells, called B cells, survive and produce antibodies.
By blocking APRIL’s signals, Voyxact lowers the production of abnormal IgA antibodies. This may help curb the immune activity that damages the kidneys in people with IgA nephropathy.
How Do I Use Voyxact?
Voyxact is given as an injection under the skin once every four weeks.
Voyxact comes as a prefilled syringe that contains a single dose. You should take Voyxact out of the refrigerator and keep it at room temperature for 15-30 minutes before using it.
You can inject Voyxact into the front of your upper legs (thighs) or the stomach area (abdomen), avoiding the area 2 inches around your belly button. If a caregiver is giving you the injection, Voyxact may also be injected in the back of your upper arm.
Do not inject into the same spot used for the previous injection. Avoid areas with moles, scars, bruises, or skin that is tender, damaged, red, scaly, or hard.
Follow the guide that comes with your medicine. Ask your health care provider if you have questions about how to inject Voyxact.
How Was Voyxact Studied for IgA Nephropathy?
The effect of Voyxact on proteinuria (protein in the urine) in adults with IgA nephropathy was studied in the VISIONARY trial. To join the trial, people needed to have IgA nephropathy confirmed by a kidney biopsy, a high level of protein in the urine, and some preserved kidney function (meaning that their kidneys were still working at least moderately well).
The trial included a total of 510 participants. They were randomly assigned to receive either an injection of Voyxact at a dose of 400 mg every four weeks or a placebo (an inactive injection). Neither the participants nor the study team knew which treatment each person received.
The median (middle) age of adults enrolled in the study was 42 years (range, 18-83 years), and mostly men were included (59.5%-65.8%). Most people were Asian (56.5%-61.8%); others were White (36.2%-39.3%) or identified as “Other” or unknown race (2%-4.2%). Almost all participants (98%) were taking medicines to lower their blood pressure, including the highest tolerated dose of an angiotensin-converting-enzyme (ACE) inhibitor, angiotensin-receptor blocker (ARB), or both. Additionally, around 40% of people were taking a medicine known as a sodium-glucose cotransporter 2 (SGLT2) inhibitor to lower their blood sugar.
The main goal of the study was to see whether Voyxact could lower the amount of protein in the urine. To measure this, the study team looked at the urine protein‑to‑creatinine ratio from a 24‑hour urine collection. They compared results from the start of the study to month 9 in the first 320 participants who were able to complete the month 9 visit.
What Did the VISIONARY Study Show?
After nine months, people receiving Voyxact had approximately 50% less protein in their urine compared with the start of the study, while people receiving a placebo had approximately 2% more protein in their urine.
The effects of Voyxact were consistent regardless of the participants’ sex, age, ethnic group, or race. Voyxact also showed similar benefits regardless of whether participants were taking an SGLT2 inhibitor medicine or how severe their protein in the urine or kidney damage was at the start of the study.
Your results may differ from what was seen in clinical studies.
How Long Does It Take for Voyxact to Work?
The VISIONARY trial showed that less protein in the urine was observed as soon as two months after starting Voyxact. These effects continued through one year of treatment with Voyxact.
Your results may differ from what was seen in clinical studies.
How Can I Prevent and Manage Voyxact Side Effects?
Most side effects with Voyxact are mild or moderate in severity and resolve on their own without pausing or stopping treatment.
People who use Voyxact may be more likely to have an infection that causes a runny nose, sore throat, and fever. The best way to prevent infection is to reduce your exposure to germs by washing your hands and avoiding people who are sick. You should also stay current on vaccinations, such as getting an annual flu vaccine. Your health care provider will check you for signs and symptoms of infections before you start and during treatment with Voyxact. Tell your health care provider right away if you develop any signs and symptoms of infection during treatment with Voyxact, including fever, chills, and cough.
If the spot where you injected yourself hurts a bit, you can put a warm or cold compress on it to get some relief. Ask your pharmacist or other health care provider whether you can take over-the-counter pain medicines to get relief.
What Kinds of Drug Interactions May Happen?
Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Voyxact is right for you. In particular, make sure that you discuss whether you are using or have recently used any medicine that can weaken your immune system. This can include medicines like chemotherapy, corticosteroids (such as dexamethasone or prednisone), methotrexate, and some biologic medicines.
You should not receive live vaccines within 30 days before starting Voyxact or during treatment with Voyxact.
What Are Other Unique Considerations to Be Aware Of?
Voyxact received an accelerated approval from the FDA because it was shown to lower protein levels in the urine. But it is not yet known whether Voyxact slows kidney damage over the long term. So, the FDA may require more studies to confirm that Voyxact offers meaningful long‑term benefits. Continued approval of the medicine may depend on the results of those studies.
How Do I Get Voyxact and What Kind of Doctor Prescribes It?
If you have IgA nephropathy, your regular health care provider may refer you to a nephrologist. A nephrologist is a specialist who treats kidney problems.
Voyxact is available through a specialty pharmacy. Once you submit a prescription for Voyxact, the specialty pharmacy PANTHERx Rare will contact you directly and coordinate delivery.
Is There Any Cost Assistance Available?
Yes. There is a cost savings and support program offered by the drugmaker that may allow you to pay as little as $0 for your Voyxact prescription. Your eligibility depends on whether you have prescription insurance and what type of insurance you have. You can find out more information at www.voyxact.com/ or by calling 855-274-3389.