The FDA has approved Gazyva ® (obinutuzumab) for treating adult patients with active lupus nephritis who are already on standard therapy. The approval is based on results from the phase 3 REGENCY trial (NCT04221477), which involved 271 patients with class 3 or 4 lupus nephritis (with or without class 5) receiving mycophenolate mofetil (MMF) and corticosteroids.

Following four initial doses in the first year, Gazyva can be administered twice yearly, offering an effective and potentially more convenient treatment option than traditional targeted therapies.

“People with lupus nephritis who achieve a complete renal response are more likely to experience preserved kidney function and delay, or even prevention, of progression to end-stage kidney disease,” said Levi Garraway, M.D., Ph.D.,

See Full Page