FDA accepts Roche’s Gazyva/Gazyvaro sBLA for lupus nephritis

The US Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Gazyva/Gazyvaro (obinutuzumab) for the treatment of lupus nephritis submitted by Swiss pharma giant Roche (ROG: SIX).

The filing acceptance is based on positive results from the Phase III REGENCY study, which showed improved complete renal response (CRR) with Gazyva/Gazyvaro plus standard therapy compared with standard therapy alone. The FDA is expected to make a decision on approval by October 2025, the company noted.

“In people with lupus nephritis, Gazyva/Gazyvaro demonstrated a complete renal response benefit, a meaningful clinical outcome linked to preservation of kidney function, and slowing or prevention of end-stage kidney disease,” said Dr Levi Garraway, Roche’s chief medical officer and head of global product development. “The FDA’s sBLA acceptance for Gazyva/Gazyvaro recognises the need to provide a more effective treatment option for people living with this devastating disease,” he added.