Promising Drug Gazyva® Gets One Step Closer to Approved Use as Lupus Nephritis Treatment
Pharmaceutical company Roche announced today that the U.S. Food and Drug Administration (FDA) has granted its antibody-targeting treatment Gazyva (obinutuzumab) the “Breakthrough Therapy Designation” (BTD) for adults with lupus nephritis (LN). The BTD classification is designed to accelerate the development and review of medicines intended to treat serious or life-threatening conditions with preliminary evidence demonstrating a substantial improvement over existing therapies.
The new designation was granted based on data from the phase II NOBILITY trial, which showed Gazyva, in combination with standard of care therapies, helped more people achieve complete renal response compared to standard of care therapies alone. Full results from the NOBILITY study will be presented at a medical meeting later this year.
Today’s announcement brings hopeful news to the lupus community as there are currently no FDA-approved drugs for LN, a serious and potentially life-threatening disease which affects up to 60% of all people with lupus. Continue to follow the Lupus Foundation of America for updates on Gazyva and learn more about medications used to treat lupus.