AstraZeneca secures FDA approval for Saphnelo autoinjector to expand treatment access for lupus patients in the United States

AstraZeneca secures FDA approval for Saphnelo autoinjector to expand treatment access for lupus patients in the United States

(IN BRIEF) AstraZeneca has secured FDA approval for a new subcutaneous autoinjector version of Saphnelo, enabling once-weekly self-administration for adults with systemic lupus erythematosus. The approval is based on Phase III trial results showing significant reductions in disease activity compared to placebo, with a safety profile consistent with the intravenous formulation. The new Saphnelo Pen offers patients greater convenience and flexibility while expanding access to an established treatment. Already approved in multiple regions and used by tens of thousands of patients globally, Saphnelo continues to play a key role in managing lupus, particularly as clinical guidelines shift toward achieving remission and reducing reliance on corticosteroids.

(PRESS RELEASE) CAMBRIDGE, 27-Apr-2026 — /EuropaWire/ — AstraZeneca has received approval in the United States for a new self-administration option of its lupus treatment Saphnelo, introducing the Saphnelo Pen, a once-weekly subcutaneous autoinjector for adult patients with systemic lupus erythematosus (SLE) who are also receiving standard therapy.

The approval from the U.S. Food and Drug Administration (FDA) is supported by data from the Phase III TULIP-SC clinical trial. The study demonstrated that subcutaneous administration of anifrolumab resulted in a statistically significant and clinically meaningful reduction in disease activity compared with placebo in patients with moderate to severe SLE. Full findings from the trial were published in the journal Arthritis & Rheumatology in early 2026.

The safety profile observed with the autoinjector was consistent with the previously established profile of Saphnelo delivered via intravenous infusion, reinforcing confidence in its use across different administration methods.

Susan Manzi, who led the TULIP-SC trial and holds leadership roles at the Allegheny Health Network, highlighted the significance of the new option, noting that the availability of a self-administered treatment improves both accessibility and convenience for patients. She also emphasized the therapy’s role in reducing disease activity and lowering the risk of organ damage in individuals living with lupus.

Louise Vetter, President and CEO of the Lupus Foundation of America, described the approval as an important milestone for the lupus community, offering patients greater flexibility in how and where they receive treatment.

From AstraZeneca’s perspective, Ruud Dobber, Executive Vice President of the BioPharmaceuticals Business Unit, noted that Saphnelo has already helped tens of thousands of patients achieve improved disease control with reduced reliance on steroids. He added that the introduction of the Saphnelo Pen represents a meaningful expansion of treatment access and therapeutic impact for people living with SLE.

Systemic lupus erythematosus is a chronic autoimmune disease that disproportionately affects women, particularly younger individuals, and is more prevalent among Asian, Black, and Hispanic populations. While corticosteroids are commonly used to manage symptoms, they are associated with potential side effects and do not address the underlying causes of the disease. Recent clinical guidance increasingly emphasises achieving remission or low disease activity while minimising steroid use.

The subcutaneous formulation of Saphnelo is already approved in the European Union and Japan and is currently under regulatory review in additional markets. The intravenous version of the treatment is approved in more than 70 countries and has been administered to over 40,000 patients worldwide. It is also the first biologic therapy for SLE to demonstrate remission data in a long-term Phase III clinical study using established remission criteria.

AstraZeneca originally obtained global rights to Saphnelo through a licensing agreement with Medarex in 2004. Following Medarex’s acquisition by Bristol Myers Squibb in 2009, AstraZeneca continues to pay royalties on US sales under the terms of an updated agreement reached in 2025.

Notes

Systemic lupus erythematosus
SLE is an autoimmune disease in which the immune system attacks healthy tissue in the body.16 It is a chronic and complex disease with a variety of clinical manifestations that can impact many organs and can cause a range of symptoms, including pain, rashes, fatigue, swelling in joints and fevers.11,12,16,17

Over 3.4 million people globally are affected by SLE.18 Living with SLE can be painful, debilitating, have a profound impact on patients’ mental and financial wellbeing.17,19-23 An estimated 50% of people with SLE have irreversible organ damage within five years of diagnosis due to long-term corticosteroid use and disease activity.9,23 Even a small reduction in daily steroid use (for example 1mg/day) can lower the risk of organ damage.24

TULIP-SC
TULIP-SC was a Phase III, multicentre, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of a subcutaneous administration of anifrolumab versus placebo in participants aged 18 to 70 years with moderate to severe SLE while receiving standard therapy (oral corticosteroids, antimalarial, and/or immunosuppressants).25

The primary endpoint was the reduction of disease activity measured using the British Isles Lupus Assessment Group based Composite Lupus Assessment (BICLA) at week 52.25 The BICLA requires improvement in all organs with disease activity at baseline with no new flares.25

In the TULIP-SC trial, Saphnelo demonstrated clinically meaningful effects across a range of outcome measures: reduction in SLE disease activity while tapering to low dose of OCS (≤7.5 mg/day), more patients achieving a BICLA response sooner, and numerically delayed time to first flare.25,26 In pre-specified secondary and exploratory endpoints, 29.0% of patients taking Saphnelo achieved DORIS remission and 40.1% attained low-level disease activity, as measured by the Low-Level Disease Activity Score (LLDAS).25,26

Participants (367) were randomised 1:1 to receive 120mg subcutaneous dose of anifrolumab or placebo administered via a pre-filled, single-use syringe.25 A planned interim analysis was conducted when the first 220 participants reached week 52 or withdrew from the study.25 The trial also includes an open-label extension period of 52 weeks for participants who completed the 52-week treatment period.25

The Saphnelo Pen
Saphnelo will be available for subcutaneous self-administration via a once-weekly 120mg autoinjector (the Saphnelo Pen) or a pre-filled syringe.

Subcutaneous administration of Saphnelo was approved in the EU and Japan. Since 2021, Saphnelo has been available in an IV infusion administered by healthcare professionals in a hospital or clinic setting. The Saphnelo Pen offers patients the choice to self-administer treatment outside of the clinic or with support from an HCP or caregiver via a simple process.

Saphnelo
Saphnelo (anifrolumab) is a first-in-class, fully human monoclonal antibody that binds to subunit 1 of the type I interferon (IFN) receptor, blocking the activity of type I IFN.5,27 Type I IFNs, such as IFN-alpha, IFN-beta and IFN-kappa, are cytokines involved in regulating the inflammatory pathways implicated in SLE.28-33

Saphnelo IV is the first biologic with remission data in SLE from a four-year placebo-controlled Phase III trial (TULIP-LTE) measured with the DORIS criteria for remission.14,15 DORIS is measured as clinical SLEDAI-2K, or “Systemic Lupus Erythematosus Disease Activity Index 2000” score of 0, physician global assessment <0.5, prednisolone/ equivalent dose of OCS dose of ≤5 mg per day and stable maintenance doses of immunosuppressants, including biologics.34

Saphnelo continues to be evaluated in diseases where type I IFN plays a key role, including Phase III trials in cutaneous lupus erythematosus, myositis, systemic sclerosis and lupus nephritis.35-38

AstraZeneca in Respiratory & Immunology
Respiratory & Immunology, part of AstraZeneca BioPharmaceuticals, is a key disease area and growth driver to the Company.

AstraZeneca is an established leader in respiratory care with a 50-year heritage and a growing portfolio of medicines in immune-mediated diseases. The Company is committed to addressing the vast unmet needs of these chronic, often debilitating, diseases with a pipeline and portfolio of inhaled medicines, biologics and new modalities aimed at previously unreachable biologic targets. Our ambition is to deliver life-changing medicines that help eliminate COPD as a leading cause of death, eliminate asthma attacks and achieve clinical remission in immune-mediated diseases.

AstraZeneca
AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Social Media @AstraZeneca.

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AstraZeneca PLC

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