Genentech, a member of the Roche Group announced that a new lymphoma medicine under the name Gazyva® (obinutuzumab) has been launched to treat adults with lupus nephritis.
Gazyva is an engineered monoclonal antibody developed to attach to CD20, a protein present only on certain types of B-cells.
The breakthrough designation received from the U.S Food and Drug Administration was provided based on data from the phase II NOBILITY study in adult patients with proliferative lupus nephritis.
The results from the clinical trial revealed that obinutuzumab combined with mycophenolate mofetil or mycophenolic acid and corticosteroids led to more cases of a complete renal response in advanced lupus nephritis cases as compared to the group receiving the standard care only.
Lupus nephritis is a potentially life-threatening manifestation of systemic lupus erythematosus that will result from inflammation of the kidneys.
It is associated with a high risk of end-stage renal disease or death.
In the NOBILITY clinical trial involving 126 participants, the sponsor met the primary endpoint of complete renal response at 52 weeks as well as the secondary endpoint which involved complete and partial renal response and improved serologic markers of disease activity.
No additional safety signals were reported.