FDA Approves First-in-Class Weekly Anifrolumab Autoinjector for Systemic Lupus Erythematosus

Today, the FDA approved anifrolumab-fnia (Saphnelo; AstraZeneca) for self-administration as a first-in-class, once-weekly autoinjector (Saphnelo Pen) for adult patients with systemic lupus erythematosus (SLE) on top of standard therapy.¹

Anifrolumab is a first-in-class, fully human monoclonal antibody that binds to subunit 1 of the type 1 interferon receptor (IFN), blocking the activity of type 1 IFNs, which are involved in regulating the inflammatory pathways implicated in SLE.

Since 2021, the treatment has been available in an intravenous (IV) infusion administered by health care professionals in a hospital or clinic setting. With this approval, the autoinjector offers patients the option to self-administer treatment outside of the clinic or with support from a health care professional or caregiver, as it will be available via a once-weekly 120 mg autoinjector or pre-filled syringe.

“The FDA approval of a subcutaneous administration option for anifrolumab is an exciting milestone for the lupus community because it offers people with systemic lupus erythematosus more convenience and choice of where and how they want to receive treatment,” Louise Vetter, president and CEO of the Lupus Foundation of America, said in a news release.

TULIP-SC Trial Supports Efficacy of Subcutaneous Anifrolumab

The approval was based on results from TULIP-SC (NCT04877691), a phase 3, multicenter, randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of a subcutaneous administration of anifrolumab vs placebo in participants aged 18 to 70 years with moderate to severe SLE while receiving standard therapy, including oral corticosteroids (OCS), antimalarials, and/or immunosuppressants.²

The primary end point was the reduction of disease activity at week 52, measured using the British Isles Lupus Assessment Group–based Composite Lupus Assessment (BICLA). The BICLA requires improvement in all organs with disease activity at baseline, with no new flares.

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

In the trial, anifrolumab demonstrated clinically meaningful effects across a range of outcome measures, including a reduction in SLE disease activity while tapering to low-dose OCS (≤ 7.5 mg/day). Additionally, more patients achieved a BICLA response sooner and had numerically delayed times to first flare. In pre-specified secondary and exploratory end points, 29.0% of patients taking anifrolumab achieved remission, defined by the Definitions of Remission in SLE, and 40.1% attained low-level disease activity, as measured by the Low-Level Disease Activity Score.

The observed safety profile was consistent with that of IV anifrolumab.¹ Specifically, during the 52 weeks of treatment, anifrolumab was well tolerated, with only 14 of the 185 patients receiving it (7.6%) discontinuing treatment due to adverse events (AEs).² The most common AEs included nasopharyngitis, upper respiratory tract infections, bronchitis, infusion-related reactions, herpes zoster, and cough.

“The approval of anifrolumab as a self-administered autoinjector is exciting news as it makes this important medicine more convenient and accessible for many more patients,” Susan Manzi, MD, MPH, principal investigator of the TULIP-SC trial and director of the Lupus Center of Excellence at the Allegheny Health Network Autoimmunity Institute, said in a news release.¹ “With its proven ability to significantly reduce disease activity and the risk of organ damage, anifrolumab has been a much-needed innovation in lupus, which is a serious and often debilitating autoimmune condition impacting millions worldwide.”

References

1. Saphnelo approved in the US for subcutaneous self-administration as a new autoinjector for the treatment of systemic lupus erythematosus. News release. AstraZeneca. April 27, 2026. Accessed April 27, 2026. https://www.astrazeneca-us.com/media/press-releases/2026/SAPHNELO-approved-in-the-US-for-subcutaneous-self-administration-as-a-new-autoinjector-for-the-treatment-of-systemic-lupus-erythematosus.html
2. Manzi S, Bruce IN, Morand EF, et al. Efficacy and safety of subcutaneous anifrolumab in systemic lupus erythematosus: a randomized, phase 3 study. Arthritis Rheumatol. doi:10.1002/art.70041