The U.S. Food and Drug Administration (FDA) has accepted Genentech’s Supplemental Biologics License Application (sBLA) for Gazyva® (Obinutuzumab), for the potential treatment of lupus nephritis, (LN, lupus-related kidney disease). A sBLA is a request submitted to the FDA to approve changes to an already licensed biologic product – in this case, a new indication.
“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 Levi Garraway, M.D., Ph.D., 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.”
Read the full press release here