AstraZeneca’s Saphnelo recommended for approval in EU

AstraZeneca (AZN) said that Saphnelo has been recommended for approval in the European Union as a self-administered once-weekly pre-filled pen for adult patients with systemic lupus erythematosus on top of standard therapy. The Committee for Medicinal Products for Human Use of the European Medicines Agency based its positive opinion on interim results from the Phase III TULIP-SC trial, which showed that subcutaneous 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 infusion. Professor Thomas Dorner, Rheumatologist and Professor of Rheumatology and Hemostaseology at Charite University Hospital, Berlin, Germany and investigator of the TULIP-SC trial said: “The positive recommendation for the subcutaneous administration of anifrolumab in the EU is highly encouraging for people living with systemic lupus erythematosus, as many still rely on oral corticosteroids, which carry significant side effects and are known to accelerate damage and functional impairment. With the latest treatment recommendations for SLE now placing increased importance on the use of biologics and earlier intervention to target remission while minimising steroids, a subcutaneous form of anifrolumab has the potential to offer broader access for patients.”