FDA Grants Accelerated Approval to Sibeprenlimab for IgA Nephropathy

The FDA has granted accelerated approval to sibeprenlimab injection (Voyxact) for reducing proteinuria in adults with primary IgA nephropathy who are at risk of disease progression.

Disease or Condition

IgAN is a serious kidney disease that occurs when an abnormal form of an antibody called immunoglobulin A (IgA) deposits in the kidneys, causing kidney inflammation and damage. This kidney damage can cause protein to leak into the urine (proteinuria) and progressive kidney function decline. The disease is often diagnosed in young adults and can progress to kidney failure.

Data Supporting Voyxact

The efficacy and safety of Voyxact were evaluated in a randomized, double-blind, placebo-controlled trial (NCT05248646) in adults with biopsy-confirmed IgAN. Half of the patients received Voyxact, and the other half received a placebo. The primary efficacy endpoint assessed the change from baseline in proteinuria (urine protein-to-creatinine ratio sampled from a 24-hour urine collection) after 9 months of treatment in the first 320 patients who had the opportunity to reach the month 9 visit. At 9 months, patients in the Voyxact group had a 50% reduction in proteinuria as compared to a 2% increase in proteinuria in the placebo group.

The recommended dosage for Voyxact is 400 mg injected subcutaneously (under the skin) once every four weeks.

Safety Information

Voyxact suppresses the immune system and may increase the risk of infections. Patients should be assessed for active infections before starting Voyxact and monitored for signs of infection during treatment. Voyxact may interfere with the immune response to vaccines and increase the risk of infection from live vaccines. Administration of live vaccines is not recommended within 30 days prior to starting Voyxact or during treatment with Voyxact.

The most common side effects of Voyxact are infections (including upper respiratory tract infection) and injection site reactions, including injection site erythema (skin redness).

Designations

Voyxact was granted accelerated approval based on the reduction of proteinuria. It has not been established whether Voyxact slows kidney function decline over the long-term in patients with IgAN. As a condition of the accelerated approval, the ongoing VISIONARY trial must be completed to confirm that Voyxact slows kidney function decline over the long-term in patients with IgAN. Continued approval may be contingent upon verification of clinical benefit in this confirmatory trial.

Voyxact also received priority review and Breakthrough Therapy designation for this indication.