- FDA approval based on phase II NOBILITY and phase III REGENCY data.
- Gazyva is the only anti-CD20 monoclonal antibody with complete renal response in lupus nephritis.
- Lupus nephritis affects over 1.7 million people globally, mainly women of color.
- Gazyva was granted Breakthrough Therapy Designation by the FDA in 2019.
FDA Approval
The FDA has approved Gazyva (obinutuzumab) for treating adult patients with active lupus nephritis who are on standard therapy. This approval is based on the drug's demonstrated superiority over standard therapy alone, as evidenced by phase II NOBILITY and phase III REGENCY studies.
Clinical Trial Results
In the REGENCY study, nearly half of the participants (46.4%) receiving Gazyva with standard therapy achieved a complete renal response, compared to 33.1% with standard therapy alone. The study also showed improvements in complement levels, reductions in anti-dsDNA, corticosteroid use, and proteinuria, indicating better disease control.
Impact on Lupus Nephritis
Lupus nephritis affects over 1.7 million people worldwide, predominantly women of color and childbearing age. Without treatment, up to one-third of patients may progress to end-stage kidney disease, requiring dialysis or transplantation. Gazyva offers a new treatment option that could prevent long-term complications.
Regulatory and Development Status
Gazyva was granted Breakthrough Therapy Designation by the FDA in 2019. The European Medicines Agency's Committee for Medicinal Products for Human Use has also issued a positive opinion recommending its approval for adults with active lupus nephritis, with a final decision from the European Commission expected soon.
Ongoing Research
Gazyva is being investigated for other conditions, including systemic lupus erythematosus, membranous nephropathy, idiopathic nephrotic syndrome, and in children and adolescents with lupus nephritis. Roche continues to explore treatments targeting immune drivers of kidney-related diseases.
