- Gazyva, combined with MMF, is approved for treating active Class III or IV lupus nephritis.
- Phase III REGENCY study showed 46.4% complete renal response with Gazyva vs. 33.1% with standard therapy.
- Lupus nephritis affects up to 135,000 people in the EU, with one-third progressing to end-stage kidney disease.
- Gazyva is also approved in the US and over 100 countries for various haematological cancers.
Approval and Study Results
The European Commission has approved Gazyva (obinutuzumab) in combination with mycophenolate mofetil (MMF) for adults with active Class III or IV lupus nephritis. This decision is based on positive outcomes from the phase II NOBILITY and phase III REGENCY studies, which demonstrated Gazyva's superiority over standard therapy alone. In the REGENCY study, 46.4% of patients achieved a complete renal response with Gazyva, compared to 33.1% with standard therapy.
Impact on Lupus Nephritis
Lupus nephritis is a serious condition affecting up to 135,000 people in the European Union, predominantly women of color and childbearing age. Current treatments often lead to end-stage kidney disease (ESKD) within 10 years for up to one-third of patients. Gazyva's approval offers a new treatment option that may delay or prevent the progression to ESKD, reducing the need for dialysis or transplant.
Additional Approvals and Research
Gazyva is also approved in the United States and over 100 countries for various haematological cancers. Recent positive phase III results in childhood idiopathic nephrotic syndrome and adult systemic lupus erythematosus highlight its potential across a range of autoimmune diseases. Ongoing research includes studies in children and adolescents with lupus nephritis and adults with membranous nephropathy.
