Roche (RHHBY.US) has been approved to use "Ocrelizumab" to treat lupus nephritis.

On October 20th, Roche (RHHBY.US) announced that obinutuzumab (marketed as Gazyva/Gazyvaro) has been approved by the FDA for a new indication, for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy. After receiving four initial doses in the first year, the treatment frequency for patients can be changed to twice a year. This drug is the first CD20-targeted therapy approved by the FDA for the treatment of lupus nephritis. This FDA approval is mainly based on positive results from the phase II NOBILITY study and the phase III REGENCY study. The REGENCY study showed that the group receiving obinutuzumab in combination with standard therapy (mycophenolate and corticosteroids) had 46.4% of patients achieve complete renal response (CRR) at week 76, compared to 33.1% in the standard therapy group (adjusted difference 13.4%, 95% CI: 2.0%-24.8%; P=0.0232). At the same time, the obinutuzumab group also showed clinically meaningful improvements in complement levels compared to the standard therapy group, with reductions in anti-dsDNA antibodies, disease activity, and inflammation markers.