AstraZeneca (AZN) said Tuesday that Saphnelo has been approved by the European Commission as a pre-filled pen for subcutaneous self-administration in adults with systemic lupus erythematosus in addition to standard therapy.

The company said the approval was based on phase 3 data that showed the subcutaneous administration of Saphnelo led to a "statistically significant and clinically meaningful reduction in disease activity," compared to placebo in patients with moderate to severe, active, autoantibody-positive systemic lupus erythematosus, who also received standard therapy.

AstraZeneca said the pre-filled pen option offers the same clinical benefits as intravenous infusion and has the potential to reach more patients.