Posted by Michael Wonder on 03 Feb 2026
Update on US regulatory review of Saphnelo subcutaneous administration in systemic lupus erythematosus
3 February 2026 - The US FDA issued a complete response letter regarding the biologics license application for Saphnelo (anifrolumab) for subcutaneous administration in adult patients with systemic lupus erythematosus.
AstraZeneca subsequently provided the information requested in the complete response letter and is committed to working with the FDA to progress the application as quickly as possible.
