FDA approves Gazyva for idiopathic nephrotic syndrome in patients aged two years and older
The FDA has approved Gazyva for patients aged two years and older with frequently relapsing or steroid-dependent childhood-onset idiopathic nephrotic syndrome who are in complete remission.
Gazyva (obinutuzumab) reduced relapse risk in the Phase III INShore study, with 95% of treated patients experiencing no relapse after week eight and remaining in complete remission at one year.
The approval introduces a B-cell-targeted therapy into a paediatric and adult nephrology setting where repeated relapses and prolonged immunosuppression can create substantial treatment burden.
Field | Content |
Article Type | Approvals |
Drug Name | Obinutuzumab |
Brand Name | Gazyva |
Company | Roche / Genentech |
Regulatory Authority | U.S. Food and Drug Administration |
Approval Type | New indication approval |
Indication | Frequently relapsing or steroid-dependent childhood-onset idiopathic nephrotic syndrome in patients in complete remission |
Patient Population | Adults and children aged two years and older |
Therapy Areas | Nephrology; rare disease; paediatrics |
Technology/Modality | Anti-CD20 monoclonal antibody |
Clinical Study | Phase III INShore |
Key Result | 95% of Gazyva-treated patients experienced no relapse after week eight and were in complete remission at one year, compared with 73% receiving mycophenolate mofetil |
Geography | United States |
What Happened | The FDA approved Gazyva to reduce relapse risk in eligible patients with childhood-onset idiopathic nephrotic syndrome. |
Why It Matters | The approval provides a new B-cell-directed option for patients with frequently relapsing or steroid-dependent disease. |
Supporting Context | Relapsing nephrotic syndrome can require repeated corticosteroid or immunosuppressive treatment, creating significant long-term treatment burden. |
Potential Impact | Gazyva may help prolong remission and reduce relapse frequency in eligible patients. |
Key Takeaway | Gazyva is now FDA approved for frequently relapsing or steroid-dependent childhood-onset idiopathic nephrotic syndrome from age two. |
What to Watch | Treatment uptake, durability of remission and positioning relative to existing immunosuppressive strategies. |
Primary Source | U.S. Food and Drug Administration |
Relevant Date | 25 September 2026 |
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