AstraZeneca Lupus Treatment Support in EU Opens Door for Self-Administration Options

An AstraZeneca treatment for adult patients with systemic lupus erythematosus (SLE) has been recommended for approval in the European Union (EU) by the Committee for Medicinal Products for Human Use (CHMP) as a once-weekly, pre-filled pen to be self-administered on top of standard therapy (1). Anifrolumab, branded as Saphnelo, yielded statistically significant and clinically meaningful disease activity reduction, versus placebo, in interim results from a Phase III trial (TULIP-SC).

AstraZeneca’s anifrolumab treatment had been previously approved by FDA in August 2021, and by the European Commission in February 2022, as an intravenous (IV) infusion to be administered by healthcare professionals in clinic or hospital settings (1–3). The company said a subcutaneous option would allow patients and/or caregivers to be able to deliver the medicine in the clinic or at home.

What is SLE, who does it affect, and how many are affected worldwide?

SLE is a chronic autoimmune condition, primarily affecting women, that causes pain, rashes, fatigue, swelling of the joints, and fevers (1). It is estimated by AstraZeneca to impact more than 3.4 million people globally, and in Europe, those diagnosed with SLE may be two to three times more at risk of death compared to the overall population.

Compounding the effects of SLE, according to AstraZeneca, are the oral corticosteroids often prescribed to provide relief from its symptoms (1). In the long term, this type of treatment has resulted in irreversible organ damage in 50% of people with SLE within five years of diagnosis. It is believed that even a small reduction in oral corticosteroid use—as little as 1mg fewer per day—can lower the risk of organ damage.

In Europe, AstraZeneca said, approximately 70% of those with SLE who are on biologic therapy are already receiving subcutaneous administration (1).

What does this approval mean for the future of subcutaneous, self-administered medication?

“The positive recommendation for the subcutaneous administration of anifrolumab in the EU is highly encouraging for people living with systemic lupus erythematosus, as many still rely on oral corticosteroids, which carry significant side effects and are known to accelerate damage and functional impairment,” said Thomas Dörner, MD, rheumatologist and professor of Rheumatology and Hemostaseology at Charité University Hospital, Berlin, and investigator of the TULIP-SC trial (1). “With the latest treatment recommendations for SLE now placing increased importance on the use of biologics and earlier intervention to target remission while minimizing steroids, a subcutaneous form of anifrolumab has the potential to offer broader access for patients.”

“Saphnelo IV infusion has already helped transform outcomes for many patients with systemic lupus erythematosus,” said Ruud Dobber, executive vice-president, BioPharmaceuticals Business Unit, AstraZeneca (1). “With this positive CHMP recommendation, we're one step closer to offering the clinically meaningful benefits of Saphnelo to more people in a convenient, once-weekly self-administration option. We are also advancing a robust development program to explore Saphnelo’s potential in other diseases where type 1 interferon plays a central role, including cutaneous lupus erythematosus, lupus nephritis, myositis, and systemic sclerosis.”

Regulatory review of AstraZeneca’s anifrolumab offering is underway in numerous countries, for both subcutaneous and IV administration, and the IV route has been approved in more than 70 countries, including the EU, United States, and Japan (1).

References

1. AstraZeneca. Saphnelo Subcutaneous Self-Administration Recommended for Approval in EU by CHMP for Systemic Lupus Erythematosus. Press Release. Oct. 17, 2025.
2. AstraZeneca. Saphnelo (anifrolumab) Approved in the US for Moderate to Severe Systemic Lupus Erythematosus. Press Release. Aug. 2, 2021.
3. AstraZeneca. Saphnelo Approved in the EU for the Treatment of Moderate to Severe Systemic Lupus Erythematosus. Press Release. Feb. 16, 2022.