The U.S.Food and Drug Administration (FDA) granted accelerated approval to Voyxact (sibeprenlimab-szsi) injection to reduce proteinuria (protein in the urine) in adults wiht primary immunoglobulin A nephropathy (IgAN) at risk for 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…