Posted by Michael Wonder on 16 Dec 2025
Saphnelo approved in the EU for subcutaneous self-administration as a new pre-filled pen for systemic lupus erythematosus
16 December 2025 - AstraZeneca’s Saphnelo (anifrolumab) has been approved in the European Union for subcutaneous self-administration as a pre-filled pen for adult patients with systemic lupus erythematosus on top of standard therapy.
The approval by the European Commission follows the positive opinion from the CHMP and was based on the positive results from the Phase 3 TULIP-SC trial.
