FDA Approves Genentech’s GAZYVA for Lupus Nephritis
Genentech, a member of the Roche Group, announced that the FDA has approved GAZYVA (obinutuzumab) for the treatment of adult patients with active lupus nephritis (LN) receiving standard therapy. The approval is supported by data from the Phase II NOBILITY and Phase III REGENCY studies, where GAZYVA demonstrated superiority over standard therapy alone, becoming the first anti-CD20 monoclonal antibody to show a complete renal response benefit in a randomized Phase III LN trial.
“The FDA’s approval of GAZYVA offers renewed hope for people with lupus nephritis and their loved ones, as it provides an important new ...
