UK MHRA approves obinutuzumab for SLE

On September 23, 2026, the UK Medicines and Healthcare products Regulatory Agency (MHRA) granted market authorization for obinutuzumab for the treatment of adults with moderate-to-severe, autoantibody-positive, active systemic lupus erythematosus (SLE) who are receiving standard therapy.¹

Authorization was based on results from the phase III ALLEGORY trial (NCT04963296), in which obinutuzumab met the primary endpoint, with 76.7% of patients attaining an SLE Responder Index 4 (SRI-4) response vs 53.5% with placebo.^1,2 Significant improvements were also observed with obinutuzumab vs placebo across key secondary endpoints, including British Isles Lupus Assessment Group (BILAG)-defined flare rates (33.8% vs 48.7%; p = 0.002), BILAG-based Composite Lupus Assessment (BICLA) response (62.0% vs 40.1%; p < 0.001), and sustained reduction in glucocorticoid dose to ≤7.5 mg/day from Week 40 through Week 52 among patients receiving ≥10 mg/day of prednisone or equivalent at baseline (80% vs 54.1%; p < 0.001).² Infections were more common in the obinutuzumab vs placebo group (68.2% vs 54.3%), though they were generally manageable and consistent with the known safety profile.² Serious adverse events were reported in 15.9% of patients receiving obinutuzumab vs 11.9% of patients receiving placebo.²