Written By: Pharmacally Medical News Desk
The European Union has approved a new subcutaneous (SC) formulation of Saphnelo (anifrolumab) as a pre-filled pen for self-administration in adults with systemic lupus erythematosus (SLE). This approval marks an important step in expanding treatment flexibility for people living with lupus across Europe.
Saphnelo is a first-in-class monoclonal antibody that targets the type I interferon (IFN) receptor, a key pathway known to be overactive in many patients with SLE. By blocking this receptor, anifrolumab reduces interferon signalling, which plays a central role in lupus-related inflammation and immune dysregulation.
Saphnelo has already been available in the EU as an intravenous (IV) infusion administered every 4 weeks in a clinical setting. The newly approved subcutaneous formulation offers a different way to receive the same targeted therapy.
Professor Thomas Dörner, Rheumatologist and Professor of Rheumatology and Hemostaseology at Charité University Hospital, Berlin, and TULIP-SC trial investigator, highlighted that EU approval of self-administered anifrolumab expands access to an important biologic for people with SLE. He emphasized its proven ability to significantly reduce disease activity and organ damage, aligning with modern treatment goals that favor earlier biologic use and reduced dependence on oral corticosteroids.
Subcutaneous Pre-Filled Pen?
The EU approval allows Saphnelo to be administered as a subcutaneous injection using a pre-filled pen, designed for self-administration by patients after appropriate training.
Key features of the new formulation:
- Route: Subcutaneous injection
- Device: Ready-to-use pre-filled pen
- Setting: At home or outside infusion centres
- Frequency: Monthly dosing, consistent with the IV regimen
This option reduces the need for regular hospital or infusion center visits, which can be a significant burden for people with chronic autoimmune diseases like lupus.
Clinical Evidence Supporting the SC Formulation
The EU approval of subcutaneous Saphnelo is supported by robust clinical evidence demonstrating that the SC formulation provides comparable pharmacokinetic exposure and clinical efficacy to the established intravenous regimen in patients with moderate to severe systemic lupus erythematosus.
The approval by the European Commission follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) and was based on positive results from the Phase III TULIP-SC trial (NCT04877691). This study confirmed that monthly subcutaneous administration of anifrolumab achieved therapeutic drug levels consistent with IV dosing while maintaining a safety profile aligned with previous studies.
Across clinical evaluations, subcutaneous Saphnelo demonstrated:
- Consistent efficacy in reducing overall disease activity
- Predictable pharmacokinetics comparable to IV administration
- No new safety signals, with adverse events consistent with the known anifrolumab safety profile
As with the IV formulation, Saphnelo is approved for use in addition to standard therapy and is not indicated for patients with severe active lupus nephritis or severe active CNS lupus.
The safety considerations for subcutaneous Saphnelo remain consistent with the established profile of anifrolumab. Commonly reported adverse effects include:
- Upper respiratory tract infections
- Injection-site reactions
- Herpes zoster infections
Patients should be monitored according to clinical guidelines, and healthcare professionals should ensure patients are properly trained before initiating self-administration.
Jeanette Andersen, Chair of Lupus Europe, noted that lupus disproportionately affects young women and severely impacts daily life. She described anifrolumab as a much-needed innovation and welcomed at-home administration as a more flexible and convenient option for patients.
Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca, stated that Saphnelo IV has already improved outcomes for tens of thousands of SLE patients. He added that approval of the subcutaneous self-administration option broadens patient choice and reflects real-world use in Europe, where a majority of biologic-treated SLE patients prefer SC administration.
About SLE
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease in which the immune system mistakenly attacks healthy tissues, causing inflammation across multiple organ systems, including the skin, joints, kidneys, heart, and nervous system. The clinical presentation varies widely, ranging from mild symptoms such as fatigue and joint pain to severe organ damage, and it most commonly affects women of childbearing age. Globally, estimates suggest that SLE affects approximately 3.4 million people, with a prevalence rate of around 44 cases per 100,000 population and a higher burden among women than men. Prevalence rates vary significantly by region, influenced by genetic, environmental, and methodological factors used in epidemiological studies. Women account for the majority of cases, reflecting both hormonal and genetic risk factors for the disease
References
Saphnelo approved in the EU for subcutaneous self-administration as a new pre-filled pen for systemic lupus erythematosus, 16 December 2025, https://www.astrazeneca.com/media-centre/press-releases/2025/saphnelo-approved-in-the-eu-for-subcutaneous-self-administration-as-a-new-pre-filled-pen-for-systemic-lupus-erythematosus.html
Subcutaneous Anifrolumab in Adult Patients with Systemic Lupus Erythematosus (Tulip SC), ClinicalTrials.gov ID NCT04877691, https://clinicaltrials.gov/study/NCT04877691
Saphnelo self-administration TULIP-SC Phase III trial meets primary endpoint in patients with systemic lupus erythematosus based on an interim analysis, 17 September 2025, https://www.astrazeneca.com/media-centre/press-releases/2025/saphnelo-met-primary-endpoint-in-tulip-sc.html
Efficacy and Safety of Subcutaneous Anifrolumab in Systemic Lupus Erythematosus: Interim Analysis of a Phase 3 Randomized Placebo-controlled Study, Abstract Number: 1545, ACR Convergence 2025, https://acrabstracts.org/abstract/efficacy-and-safety-of-subcutaneous-anifrolumab-in-systemic-lupus-erythematosus-interim-analysis-of-a-phase-3-randomized-placebo-controlled-study/
Tian J, Zhang D, Yao X, Huang Y, Lu Q. Global epidemiology of systemic lupus erythematosus: a comprehensive systematic analysis and modelling study. Ann Rheum Dis. 2023 Mar;82(3):351-356. doi: 10.1136/ard-2022-223035. Epub 2022 Oct 14. PMID: 36241363; PMCID: PMC9933169.
Alexander, T., Sewerin, P., Strangfeld, A. et al. Real-World Prevalence, Incidence and Management of Systemic Lupus Erythematosus in Germany: A Retrospective Claims Data Analysis. Rheumatol Ther 12, 237–254 (2025). https://doi.org/10.1007/s40744-024-00735-5