The Lupus Foundation of America Inc reported on Monday that the US Food and Drug Administration (FDA) has approved Gazyva (obinutuzumab), developed by biotechnology company Genentech, a member of the Roche Group (SIX: RO, ROG) (OTCQX: RHHBY), as a treatment for adults with lupus nephritis (LN), also known as lupus-related kidney disease.

Gazyva is a type II humanised anti-CD20 monoclonal antibody that works by targeting and eliminating certain B cells, which are believed to promote inflammation which causes kidney damage in LN. LN occurs in up to 60% of people with lupus and can lead to permanent kidney damage and even kidney failure if not effectively treated.

The FDA approval is based on positive results of the Phase II NOBILITY and Phase III REGENCY trials. In the REGENCY trial, nearly half (46.4%) of those treated with Gazyva in addition to standard therapy (mycophenolate mofetil and glucocorticoids) achieved a complete renal response, meaning their kidney function returned to normal with little to no protein in the urine. This represents a statistically significant and clinically meaningful improvement in kidney outcomes for people affected by lupus nephritis, because restoring normal kidney function and reducing protein in the urine can prevent long-term kidney damage and reduce the risk of kidney failure.

According to the Lupus Foundation of America, Gazyva is the only anti-CD20 monoclonal antibody to demonstrate a complete renal response benefit in lupus nephritis in a randomised Phase III study. For eligible patients living with lupus nephritis, Gazyva can be administered twice yearly following four initial doses in the first year.

The approval of Gazyva provides another option, though experts stress the continued need for additional innovation as only 4 in 10 people living with LN, on average, respond to these therapies and a significant proportion experience cycles of disease flares and remission.