REG - AstraZeneca PLC - Saphnelo self-administration approved in the US

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RNS Number : 9471B  AstraZeneca PLC  27 April 2026

27 April 2026

 

Saphnelo approved in the US for subcutaneous self-administration as a new
autoinjector for the treatment of systemic lupus erythematosus

 

First-in-class Saphnelo Pen now offers greater flexibility and convenience,
reaching a wider group of patients

 

AstraZeneca's Saphnelo (anifrolumab) has been approved in the US for
self-administration as a once-weekly autoinjector, the Saphnelo Pen, for the
treatment of adult patients with systemic lupus erythematosus (SLE) on top of
standard therapy.

 

The approval by the US Food and Drug Administration (FDA) was based on results
from the Phase III TULIP-SC trial, which showed that subcutaneous (SC)
administration of Saphnelo led to a statistically significant and clinically
meaningful reduction in disease activity compared to placebo in participants
with moderate to severe SLE while receiving standard therapy.(1,2) Full
results from the TULIP-SC trial were published in Arthritis & Rheumatology
(https://www.astrazeneca.com/media-centre/press-releases/2026/saphnelo-self-administration-tulip-sc-trial-demonstrates-statistically-significant-clinically-meaningful-reduction-sle-disease-activity.html)
in January 2026.

 

The safety profile observed was consistent with the known clinical profile of
Saphnelo administered as an intravenous (IV) infusion.(3-5)

 

Susan Manzi, MD, MPH, chair of the Allegheny Health Network (AHN) Medicine
Institute, director of the Lupus Center of Excellence at the AHN Autoimmunity
Institute and principal investigator of the TULIP-SC trial, said: "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. 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."

 

Louise Vetter, President and Chief Executive Officer, Lupus Foundation of
America, said: "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."

 

Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit,
AstraZeneca, said: "Since its launch, Saphnelo IV infusion has
helped tens of thousands of people with systemic
lupus erythematosus achieve lower disease activity with fewer steroids and
has been shown to help many achieve remission. The approval of the Saphnelo
Pen represents a significant step forward in expanding Saphnelo's clinical
benefits to more people living with systemic lupus erythematosus."

 

SLE is amongst the leading causes of death in young women in the US and is
more common amongst Asian, Black or Hispanic populations.(6,7) While oral
corticosteroids are often used to provide relief from SLE symptoms, they are
associated with adverse events and do not target the underlying drivers of the
disease.(8-10) Recent updates to clinical guidelines elevate the importance of
treating to target remission or low disease activity and minimising the use of
oral corticosteroids.(11,12)

 

Subcutaneous administration of Saphnelo is approved in the EU
(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)
and Japan
(https://www.astrazeneca.co.jp/media/press-releases1/2026/202602192.html) and
under regulatory review in several other countries around the world. Saphnelo
IV infusion is approved for the treatment of moderate to severe SLE in more
than 70 countries worldwide, including the US and EU. To date, more than
40,000 patients globally have been treated with Saphnelo.(13) Saphnelo IV is
the first biologic with remission data in SLE from a four-year
placebo-controlled Phase III trial (TULIP-LTE) and was measured with the DORIS
criteria for remission.(14,15)

 

Financial considerations

AstraZeneca acquired global rights to Saphnelo through an exclusive license
and collaboration agreement with Medarex, Inc. in 2004. The option for Medarex
to co-promote the product expired on its acquisition by Bristol-Myers Squibb
(BMS) in 2009. Under the agreement, updated in 2025, AstraZeneca will pay BMS
a mid-teens royalty for sales in the US.

 

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 (https://www.astrazeneca.com/)

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 (http://www.astrazeneca.com/) and follow the
Company on Social Media @AstraZeneca.
(https://www.linkedin.com/company/astrazeneca)

 

Contacts

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.

 

References

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Matthew Bowden

Company Secretary

AstraZeneca PLC

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