FDA approves Gazyva for idiopathic nephrotic syndrome
News Context
At a glance
- The US Food and Drug Administration has approved Gazyva, also known as Gazyvaro and generically as obinutuzumab, for the treatment of the rare kidney disorder idiopathic nephrotic syndrome,...
- The regulatory decision covers adults and children aged two years and older who are in remission.
- The approval is based on data from the INSHORE clinical study, which evaluated the efficacy and safety of the medication in 85 patients starting from two years of...
The US Food and Drug Administration has approved Gazyva, also known as Gazyvaro and generically as obinutuzumab, for the treatment of the rare kidney disorder idiopathic nephrotic syndrome, according to an agency announcement published on September 25, 2026.
The regulatory decision covers adults and children aged two years and older who are in remission. Gazyva was previously approved for certain types of cancer as well as for adults with active lupus nephritis.
Clinical Trial Findings on Efficacy and Safety
The approval is based on data from the INSHORE clinical study, which evaluated the efficacy and safety of the medication in 85 patients starting from two years of age. Results from the trial demonstrated a 73 percent higher efficacy for Gazyva compared to standard therapy.