FDA approves Gazyva to reduce idiopathic nephrotic syndrome relapse

The FDA approved Gazyva (obinutuzumab) injection to reduce the risk of relapse in adults and children 2 years of age and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission.

The approval was supported by INSHORE, a phase 3 study of 85 patients. Patients received intravenous Gazyva or twice-daily oral mycophenolate mofetil. The FDA said 73% of patients in the Gazyva group met the primary endpoint: a first morning urine protein-creatinine ratio of no more than 0.2 g/g at Week 52 without relapse from Week 8 to Week 52. The FDA said this proportion was significantly greater than in the standard-of-care group.

Common side effects include infections, infusion-related reactions and neutropenia. The label carries a boxed warning for hepatitis B virus reactivation and progressive multifocal leukoencephalopathy.