Roche Grabs Breakthrough Status for Lupus Nephritis Drug
The FDA has grantedn Roche breakthrough therapy designation for its chemotherapy, Gazyva (obinutuzumab), to treat lupus nephritis alongside standard of care.
Lupus nephritis is a serious inflammation of the kidneys caused by the chronic autoimmune disorder systemic lupus erythematosus.
The agency granted the drug breakthrough status based on a phase 2 placebo-controlled, clinical trial of 126 people. The trial showed that Gazyva, in combination with the standard of care (mycophenolate mofetil or mycophenolic acid and corticosteroids), was more efficient compared to the placebo with standard care in achieving complete renal response at the one year mark.