Positive CHMP Recommendation for Subcutaneous Saphnelo

AstraZeneca PLC announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the approval of Saphnelo (anifrolumab) for subcutaneous self-administration in adult patients with systemic lupus erythematosus (SLE). This recommendation is based on the Phase III TULIP-SC trial, which demonstrated that subcutaneous administration of Saphnelo significantly reduced disease activity compared to placebo. The safety profile was consistent with the known clinical profile of Saphnelo administered intravenously. The CHMP's positive opinion brings AstraZeneca closer to offering a convenient, once-weekly self-administration option for SLE patients. Saphnelo is already approved in more than 70 countries for intravenous administration. The company is also exploring Saphnelo's potential in other diseases where type 1 interferon plays a central role.