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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