Roche has welcomed MHRA marketing authorisation for Gazyvaro, indicated for adults with moderate to severe, active, autoantibody-positive systemic lupus erythematosus receiving standard therapy. The company said the decision provides a new targeted option for people living with the most common form of lupus.
Gemma Boni, UK Nephrology/Rheumatology Lead, Roche Products Limited, said: “We are delighted to receive marketing authorisation for Gazyvaro for adult patients living with the most common form of lupus, systemic lupus erythematosus. SLE is a severe autoimmune disease that accounts for 70% of all lupus cases and disproportionately affects women of colour.”
She added: “We will continue to work with relevant reimbursement authorities to try to ensure our medicine is accessible to patients on the NHS as soon as possible.”
Professor Ed Vital, Honorary Consultant Rheumatologist at Leeds Teaching Hospitals NHS Trust, explained: “As a doctor treating lupus, I see a lot of people with unacceptable symptoms due to active disease and high doses of steroids which together affect quality of life and may cause long term organ damage. In ALLEGORY, we found that obinutuzumab reduced disease activity and flares while at the same time allowing patients to cut their steroid doses.”
He added: “ALLEGORY also showed a generally well tolerated safety profile for obinutuzumab so today’s MHRA decision is a genuine addition to what I may offer to lupus patients in clinic.”
Gazyvaro is a Type II engineered humanised monoclonal antibody targeting CD20 on B cells, depleting disease‑causing cells to help control inflammation and autoimmune activity. After loading doses on Day 1 and Day 15, it is administered at 6 and 12 months in Year 1, followed by maintenance infusions every 6 months.
The MHRA licence is based on the phase 3 ALLEGORY study, which met its primary endpoint, with 76.7% of participants achieving an SRI‑4 response versus 53.5% on standard therapy alone. Statistically significant improvements were also seen across key secondary endpoints, including BICLA response rates, glucocorticoid reduction and flare rates.
Although infections were more common with obinutuzumab, they were generally manageable and consistent with the known safety profile. Serious adverse events occurred in 15.9% of Gazyvaro‑treated patients versus 11.9% on placebo.
SLE affects around 50,000 people in the UK and disproportionately impacts women. Symptoms vary widely and diagnosis can take years, during which repeated flares may worsen disease severity and organ damage. The approval adds a new targeted therapy to address ongoing unmet need.
