Andrea Callaway, president and founder of The Nephrotic Syndrome Foundation, discusses the FDA approval of Gazyva (obinutuzumab) for idiopathic nephrotic syndrome (INS) and what the approval means for affected families.
What Is Idiopathic Nephrotic Syndrome?
INS is a rare autoimmune kidney disease that’s commonly diagnosed in early childhood. It causes the kidneys to leak large amounts of protein into the urine, which can result in weight gain, swelling, and fatigue. Patients may also experience an increased risk of complications, such as infections and blood clots.
Steroids have traditionally been used to treat patients with INS, but between 60% and 90% of patients experience relapse. Furthermore, steroid-related side effects can make long-term treatment challenging.
The US Food and Drug Administration (FDA) Approves Obinutuzumab for INS
On September 25, 2026, obinutuzumab received FDA approval to reduce the risk of relapse in adults and children ages two years and older with frequently relapsing or steroid-dependent childhood-onset INS who are in complete remission. It’s the first treatment approved for INS in more than 70 years.
Obinutuzumab is a monoclonal antibody that targets B cells involved in immune activity. It’s designed to help INS patients maintain remission and lower the risk of relapses.
Study Findings Support Obinutuzumab’s Efficacy
Results from the INShore clinical trial (NCT05627557) were announced by Roche on October 28, 2025. The INShore study was a phase 3, open-label, randomized clinical trial evaluating the efficacy and safety of obinutuzumab compared to mycophenolate mofetil (MMF) in patients with childhood-onset INS.
The study found that 95% of participants receiving obinutuzumab experienced no relapses after week 8 and were in complete remission by week 52, compared with 73% of participants receiving MMF.
Secondary endpoints included statistically significant and clinically meaningful benefits in overall relapse-free survival, median time to first relapse or death, and the number of relapses through week 52, all compared with MMF.
No new safety signals were observed with obinutuzumab.
For more information, visit: https://www.gene.com/media/statements/ps_092526
To learn more about idiopathic nephrotic syndrome and other rare kidney and urinary diseases, visit: https://checkrare.com/diseases/kidney-and-urinary-diseases/