Roche announced that the US Food and Drug Administration (FDA) has approved Gazyva/ Gazyvaro (obinutuzumab) for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy, as well as a shorter 90-minute infusion time after the first infusion, for eligible patients.

Following four initial doses in the first year, Gazyva/Gazyvaro can be administered twice yearly, offering an effective and potentially more convenient treatment option than traditional targeted therapies.

“People with lupus nephritis who achieve a complete renal response are more likely to experience preserved kidney function and delay, or even prevention, of progression to end-stage kidney disease,” said Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development.

“The approval of Gazyva/Gazyvaro by the FDA marks an important step towards a potential new standard of care for lupus nephritis, one that could allow clinicians to offer their patients more effective disease control.”

“As a severe and potentially life-threatening disease, lupus nephritis greatly disrupts daily life with chronic pain, fatigue, and the constant fear of worsening kidney health,” said Louise Vetter, President and Chief Executive Officer, Lupus Foundation of America. “The FDA’s approval of Gazyva/Gazyvaro offers renewed hope for people with lupus nephritis and their loved ones, as it provides an important new treatment option that has the potential to prevent long-term complications, including kidney failure.”

This approval is based on positive results from the phase II NOBILITY and phase III REGENCY studies. In REGENCY, data showed that nearly half of the participants (46.4%) on Gazyva/Gazyvaro in combination with standard therapy achieved a complete renal response (CRR) compared to 33.1% on standard therapy alone.

This was accompanied by clinically meaningful improvements in complement levels and reductions in anti-dsDNA, corticosteroid use, and proteinuria, all signalling improved disease control. The safety profile of Gazyva/Gazyvaro was consistent with the well-characterised profile observed in its haematology-oncology indications.

Lupus nephritis affects more than 1.7 million people worldwide. It disproportionately impacts women, mostly women of colour and of childbearing age, who often face more severe disease.6 If left untreated, up to one-third of individuals can progress to end-stage kidney disease, which often requires dialysis or transplantation.

Gazyva/Gazyvaro was granted Breakthrough Therapy Designation by the FDA in 2019 based on data from the phase II NOBILITY study. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recently issued a positive opinion recommending the approval of Gazyva/Gazyvaro for adults with active lupus nephritis, with a final decision from the European Commission expected in the near future.