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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on interim results from the Phase III TULIP-SC trial, which showed that 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.
The safety profile observed was consistent with the known clinical profile of Saphnelo administered as an intravenous (IV) infusion.
Posted In: AZN
