FDA approves a new treatment for primary immunoglobulin A nephropathy
Voyxact (sibeprenlimab-szsi) injection reduces proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression.
A humanized IgG2 monoclonal anybody that selectively inhibits the cytokinine A proliferation inducing lligand (APRIL) , by preventing it from binding to its receptors.
APRIL is considered to be a key driver in the pathogenesis of IgA nephropathy and mediates antibody class switching in mature B cells in plasma cell survival, leading to the production of IgA pathogenic galactose deficient IgA1.
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 proteinuria and progressive kidney function decline.
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.
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 once every four weeks.
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.
It has not been established whether Voyxact slows kidney function decline over the long-term in patients with IgAN.