Posted by Michael Wonder on 18 Sep 2019
FDA grants breakthrough therapy designation for Roche’s Gazyva (obinutuzumab) in lupus nephritis
18 September 2019 - There are currently no U.S. FDA approved medicines for lupus nephritis.
Roche today announced that the U.S. FDA has granted breakthrough therapy designation to Gazyva (obinutuzumab) for adults with lupus nephritis.
This designation was granted based on data from the phase II NOBILITY study in adult patients with proliferative lupus nephritis which showed Gazyva, in combination with standard of care (mycophenolate mofetil or mycophenolic acid and corticosteroids), demonstrated enhanced efficacy compared to placebo plus standard of care alone in achieving complete renal response at one year.
