NICE backs Roche lupus drug that supports kidney function

Roche's Gazyvaro, a drug that can restore kidney function in people living with lupus nephritis, has been cleared for use by the NHS in England and Wales.

Around 12,000 people with kidney disease associated with the autoimmune disorder systemic lupus erythematosus (SLE) – an autoimmune disorder causing widespread inflammation and organ damage – will now be able to access treatment with anti-CD20 antibody Gazyvaro (obinutuzumab), according to reimbursement authority NICE.

A draft recommendation published today by the health technology assessment (HTA) agency backs the use of Gazyvaro, given as an intravenous infusion twice-yearly after an initial induction regimen, in combination with mycophenolate mofetil (MMF) for adults with lupus whose kidneys show damage to blood vessels. Around 60% of people with lupus will develop lupus nephritis at some point during their illness.

Gazyvaro has been submitted to the Scottish Medicines Consortium (SMC) for lupus nephritis, with no dates for the appraisal available yet, while Northern Ireland tends to follow NICE's lead, but has no set timeline for adoption.

Clinical trials showed 46% of patients achieved normal or near normal kidney function, compared with just 33% on existing treatment with MMF alone, said NICE in a statement. Lupus nephritis affects more than 1.7 million people worldwide, predominantly women of colour and childbearing age, with up to one-third of patients progressing to end-stage kidney disease.

Also used to treat certain blood cancers, Gazyvaro had its label extended to include lupus nephritis last year and has also shown efficacy in the phase 3 ALLEGORY trial more broadly in people living with the autoimmune disease, including those without kidney involvement.

In public meetings, patients with lupus nephritis told NICE that the disease dominates their lives with crushing fatigue, painful swelling, disrupted sleep, and the constant anxiety of unpredictable flare-ups that can derail work, relationships, and daily routines.

"There is a clear need for more treatment options in lupus nephritis to better control flares and prevent the accumulation of damage and disease progression," said Debbie Kinsey, health information, policy and research manager at patient advocacy organisation Lupus UK.

"Lupus nephritis has a significant impact on people living with the disease: on their quality of life, mental health, and their life expectancy," she added. "We hope that the introduction of new treatments will lead to better outcomes for people living with lupus nephritis."

Roche recorded $728 million in sales of Gazyvaro (sold as Gazyva in some markets) in the first nine months of 2025, up 17%, and GlobalData has previously said that approval for lupus nephritis and SLE could drive annual sales to $1.7 billion by the end of the decade.