The US Food and Drug Administration granted accelerated approval to Voyxact (sibeprenlimab-szsi) injection for reducing proteinuria in adults with primary immunoglobulin A nephropathy. The disease occurs when abnormal IgA antibodies deposit in the kidneys, causing inflammation and damage. The condition is typically diagnosed in young adults and may lead to kidney failure.

Voyxact's efficacy and safety were evaluated in a randomized, double-blind, placebo-controlled trial (NCT05248646) in adults with biopsy-confirmed disease. Patients were assigned to receive either Voyxact or placebo. The primary endpoint was the change from baseline in urine protein-to-creatinine ratio collected from a 24-hour urine sample at Month 9 among the first 320 patients who reached that assessment. At Month 9, the Voyxact group demonstrated a 50% reduction in proteinuria, whereas the placebo group showed a 2% increase. The recommended dosage is 400 mg administered subcutaneously every 4 weeks.

Safety considerations include immunosuppression and associated infection risk. Patients should undergo evaluation for active infection prior to treatment initiation and be monitored for infectious complications throughout therapy. Because the therapy may attenuate vaccine responses, live vaccines should not be administered within 30 days before treatment initiation or during therapy. Common adverse events include infections, such as upper respiratory tract infection, and injection site reactions, including erythema.

Voyxact received accelerated approval based on proteinuria reduction. Its effect on long-term preservation of kidney function has not been established. Continued approval may depend on confirmatory evidence from the ongoing VISIONARY trial, which is designed to assess whether the therapy slows renal function decline. The treatment also received priority review and Breakthrough Therapy designation.

Source: FDA