FDA Approves Gazyva as First New Therapy for Idiopathic Nephrotic Syndrome in Decades

The U.S. Food and Drug Administration (FDA) has approved Gazyva (obinutuzumab) to reduce the risk of relapse in adults and children aged 2 years and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome (INS) who are in complete remission. This marks the first FDA-approved therapy specifically for INS in approximately 70 years. The approval is supported by findings from the phase 3 INShore trial, which showed 95% of Gazyva-treated patients had no relapses after week 8 and were in complete remission at 52 weeks, compared to 73% of those receiving mycophenolate mofetil (MMF).