FDA Approves Otsuka’s ‘Anti-APRIL’ Therapy Targeting A Type Of Kidney Disease

Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical, Co. Ltd. (Otsuka) announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Voyxact (sibeprenlimab-szsi) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. Proteinuria is the presence of abnormal quantities of protein in the urine, which may indicate damage to the kidneys.

Voyxact blocks A-PRoliferation-Inducing-Ligand (APRIL). Blocking APRIL reduces levels of serum galactose-deficient IgA1 (Gd-IgA1), which is implicated in the development of IgAN, a progressive, immune-mediated, chronic kidney disease that typically . . .