Trial Profile

A Multicentre, Randomised, Double-Blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus

Status: Active, no longer recruiting

Phase of Trial: Phase III

Latest Information Update: 02 Mar 2026

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At a glance

03 Feb 2026 According to AstraZeneca media release, decision from the FDA on the updated application for Saphnelo SC is expected in the first half of 2026.
03 Feb 2026 According to AstraZeneca media release, US Food and Drug Administration (FDA) issued a complete response letter (CRL) regarding the Biologics License Application (BLA) for Saphnelo (anifrolumab) SC in adult patients with systemic lupus erythematosus (SLE). AstraZeneca subsequently provided the information requested in the CRL and is committed to working with the FDA to progress the application as quickly as possible.
13 Jan 2026 Planned End Date changed from 18 Nov 2026 to 6 Nov 2026.

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