Posted by Michael Wonder on 17 Oct 2025
Saphnelo subcutaneous self-administration recommended for approval in EU by CHMP for systemic lupus erythematosus
17 October 2025 - Recommendation based on TULIP-SC Phase III trial results showing first in class Saphnelo reduced disease activity via once-weekly subcutaneous administration
AstraZeneca's Saphnelo (anifrolumab) 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.
