The US Food and Drug Administration (FDA) has approved Gazyva (obinutuzumab) to reduce the risk of relapse in adult and pediatric patients 2 years of age and older with frequently relapsing or steroid dependent childhood-onset idiopathic nephrotic syndrome (INS) who are in complete remission.
INS is a rare, autoimmune kidney disease characterized by unpredictable relapses that cause fatigue, swelling, weight gain and increased susceptibility to infections and clotting, as well as anxiety, depression and reduced self-esteem, brought on by the fear of relapse and social isolation. It is usually diagnosed in early childhood and is the most common form of primary glomerular disease in children.
Obinutuzumab is a humanized type II anti-CD20 monoclonal antibody that binds to the CD20 antigen, a proven target for CD20+ B cells.
The approval is based on results from the phase 3 INShore clinical trial (NCT05627557). More obinutuzumab-treated patients experienced no relapses after week 8 and were in complete remission at one year (95%) compared with mycophenolate mofetil (MMF) (73%). Analysis of key secondary endpoints showed statistically significant and clinically meaningful benefits with obinutuzumab with an increase in those with overall relapse-free survival, median time to first relapse or death, and fewer relapses from baseline to week 52, all compared with MMF. Additionally, no new safety signals were observed.
For more information, visit https://www.gene.com/media/statements/ps_092526?utm_source=Linkedin+-+Genentech&utm_medium=Organic-Social&utm_campaign=INS+Approval&Campaign+Term=Corporate&Content=LinkedIn
To learn more about rare kidney conditions, visit https://checkrare.com/diseases/kidney-and-urinary-diseases/