What is Voyxact (sibeprenlimab-szsi) a medicine for?

Voyxact (sibeprenlimab-szsi), a drug indicated for the treatment of primary immunoglobulin A nephropathy (IgAN), is a proliferation-inducing ligand (APRIL) blocker designed to reduce proteinuria in adult patients at risk of disease progression. IgAN is an autoimmune disease characterized by the accumulation of galactose-deficient IgA1 (Gd-IgA1) complexes in the kidneys, leading to progressive loss of kidney function and increased risk of progression to end-stage renal disease.

Voyxact works by selectively binding to and inhibiting the activity of APRIL. APRIL is a cytokine in the tumor necrosis factor (TNF) family that mainly promotes the survival of B cells and their class switching to produce IgA, especially the production of pathogenic Gd-IgA1. By reducing Gd-IgA1 levels, Voyxact is expected to slow kidney damage and reduce the risk of developing end-stage renal disease.

The drug's accelerated approval by the FDA was based on an interim analysis of a prospective Phase 3 clinical trial, which showed that during nine months of treatment, the Voyxact group reduced proteinuria by 51% (P<0.0001), compared with the placebo group. Voyxact is self-administered via subcutaneous injection every four weeks for patient convenience.

However,the use of Voyxact also comes with some caveats and precautions. Patients should pay attention to immunosuppression and increased risk of infection when using this drug. Common adverse reactions include upper respiratory tract infection and erythema at the injection site. Therefore, doctors need to fully assess the patient's health status when prescribing to ensure safe and effective treatment.

Overall,Voyxact provides a new treatment option for IgAN patients that may play an important role in slowing disease progression. However, further research and clinical data are needed to support its long-term benefits and impact on renal function decline.

Reference materials:https://go.drugbank.com/drugs/DB18919