EMA recommends Gazyvaro for active systemic lupus erythematosus
- In a 303-patient study, 76.7% of patients receiving obinutuzumab responded after 52 weeks, versus 53.5% receiving placebo.
- The study also found reduced corticosteroid use and fewer disease flares with obinutuzumab.
- Common side effects included upper respiratory tract and urinary tract infections.
- The European Commission will decide whether to extend Gazyvaro’s EU marketing authorisation.
Proposed indication
The European Medicines Agency (EMA) has recommended extending Gazyvaro (obinutuzumab) use in the EU to adults with moderate to severe, active systemic lupus erythematosus (SLE). It would be an add-on treatment for patients who test positive for specified antibodies and whose disease remains active despite standard therapy.
Study results
The recommendation is based on a randomised, double-blind study of 303 adults with active SLE despite standard treatment. After 52 weeks, 76.7% of patients receiving Gazyvaro responded according to the SLE Responder Index (SRI4), compared with 53.5% receiving placebo. The study also found that patients receiving Gazyvaro reduced corticosteroid use while maintaining disease control and experienced fewer disease flares.
Safety and next steps
Frequently reported side effects in patients with SLE included upper respiratory tract and urinary tract infections. The EMA’s Committee for Medicinal Products for Human Use (CHMP) opinion will be sent to the European Commission, which will decide on extending the EU-wide marketing authorisation. Pricing and reimbursement decisions will be made by individual Member States.
Source: EMA