The US Food and Drug Administration (FDA) has given the go-ahead to Genentech’s Gazyva (obinutuzumab) in adult and paediatric patients two years of age and older. 

It is approved to reduce the risk of relapse in patients with frequently relapsing or steroid dependent childhood-onset idiopathic nephrotic syndrome (INS) who are in complete remission.  

INS is a rare, kidney-related autoimmune disease, usually diagnosed in early childhood.  

In the Phase III INShore study, a greater proportion of people experienced no relapses after week eight and were in complete remission at one year (week 52) with Gazyva (95%) compared with mycophenolate mofetil (MMF) (73%).  

Analysis of key secondary endpoints showed statistically significant and clinically meaningful benefits with Gazyva with an increase in those with overall relapse-free survival (RFS), median time to first relapse or death, and fewer relapses from baseline to week 52, all compared with MMF. 

“Gazyva is the first FDA-approved treatment option for idiopathic nephrotic syndrome in 70 years, introducing a substantial advancement for children and families who have long relied on steroids and faced high rates of relapse,” said Dr Levi Garraway, Chief Medical Officer and Head of Global Product Development. “By directly targeting B cells to more effectively control disease activity, this first-of-its-kind therapy equips healthcare providers with an option that provides the possibility of lasting remission, giving families the freedom to focus on their child’s growth and potential.” 

This is the second FDA approval of Gazyva in immune-mediated disease, following the approval in adult lupus nephritis (LN) last year. Gazyva is also being investigated in paediatric LN and is under FDA review in primary membranous nephropathy and systemic lupus erythematosus (SLE), based on the positive Phase III MAJESTY and ALLEGORY trials, respectively.