AstraZeneca’s Saphnelo approved in EU for subcutaneous self-admin

AstraZeneca’s (AZN) Saphnelo has been approved in the European Union, EU, for subcutaneous self-administration as a pre-filled pen for adult patients with systemic lupus erythematosus, SLE, on top of standard therapy. The approval by the European Commission follows the positive opinion from the Committee for Medicinal Products for Human Use, CHMP, and was based on the positive results from the Phase III TULIP-SC trial. In the trial, subcutaneous, SC, administration of Saphnelo led to a statistically significant and clinically meaningful reduction in disease activity compared to placebo in participants with moderate to severe, active, autoantibody-positive SLE while receiving standard therapy.