Roche (RHHBY.US) submits breakthrough therapy regulatory application.
1min read Roche (RHHBY.US) today announced that the U.S. FDA has accepted the company's supplemental Biologics License Application (sBLA) for obinutuzumab, an anti-CD20 antibody, for the treatment of lupus nephritis. The FDA expects to complete its review by October 2025. The press release noted that obinutuzumab is the first anti-CD20 monoclonal antibody to demonstrate complete renal response (CRR) in a randomized Phase 3 clinical trial for lupus nephritis.
Obinutuzumab is a humanized monoclonal antibody that targets CD20, a protein expressed by certain types of B cells. In lupus nephritis, pathogenic B cells drive persistent inflammation that damages the kidneys. By depleting pathogenic B cells with obinutuzumab, the underlying cause of lupus nephritis can be targeted to help better control the disease, protect the kidneys from further damage, and potentially prevent or delay progression to end-stage renal disease.