Positive CHMP opinion for anifrolumab subcutaneous self-administration for adult patients with SLE

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended European Commission (EC) approval of anifrolumab as a self-administered once-weekly pre-filled pen for adult patients with systemic lupus erythematosus (SLE), on top of standard therapy.¹  

The positive opinion is based on interim results from the phase III TULIP-SC trial (NCT04877691), which evaluated the efficacy and safety of the subcutaneous administration of anifrolumab compared with placebo in participants with moderately to severely active, autoantibody-positive SLE, with both treatment groups receiving standard therapy.^1,2 The TULIP-SC interim results will be presented during the American College of Rheumatology (ACR) Convergence 2025, October 24–29, 2025, Chicago, US (Abstract Number: 1545).^1,2 

Anifrolumab had been previously approved by the U.S. Food and Drug Administration (FDA) in 2021 and by the EC in 2022 for the treatment of moderate-to-severe SLE as an intravenous (IV) infusion administered by a healthcare provider.^3,4 This new recommendation for approval of a self-administered formulation has the potential to offer broader access for patients.¹