Roche's groundbreaking therapy submits regulatory application.

Roche (RHHBY.US) announced today that the U.S. FDA has accepted the company's supplemental biologics license application (sBLA) for the anti-CD20 antibody obinutuzumab for the treatment of lupus nephritis. The FDA expects to complete the review by October 2025. The press release notes that obinutuzumab is the first anti-CD20 monoclonal antibody to demonstrate the benefit of complete renal response (CRR) in a randomized phase 3 clinical trial for lupus nephritis. Obinutuzumab is a humanized anti-CD20 monoclonal antibody, with CD20 being a protein expressed by certain types of B cells. In lupus nephritis, pathogenic B cells drive persistent inflammation, leading to kidney damage. By depleting pathogenic B cells using obinutuzumab, the underlying cause of lupus nephritis can be targeted to better control the disease, protect the kidneys from further damage, and potentially prevent or delay the progression of the disease to end-stage kidney disease.