REG - AstraZeneca PLC - Subcutaneous Saphnelo approved in EU

AstraZenecaAnnouncement

Tue 07:10

For best results when printing this announcement, please click on link below:
https://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20251216:nRSP6545La&default-theme=true

RNS Number : 6545L  AstraZeneca PLC  16 December 2025

16 December 2025

 

Saphnelo approved in the EU for subcutaneous self-administration as a new
pre-filled pen for systemic lupus erythematosus

 

Convenient subcutaneous option has potential to reach more patients with same
clinical benefits as Saphnelo IV infusion

 

AstraZeneca's Saphnelo (anifrolumab) has been approved in the European Union
(EU) for subcutaneous self-administration as a pre-filled pen for adult
patients with systemic lupus erythematosus (SLE) on top of standard therapy.

 

The approval by the European Commission follows the positive opinion
(https://www.astrazeneca.com/media-centre/press-releases/2025/saphnelo-subcutaneous-self-administration-recommended-for-approval-in-eu-by-chmp-for-systemic-lupus-erythematosus.html)
from the Committee for Medicinal Products for Human Use (CHMP) and was based
on the positive results from the Phase III TULIP-SC trial.(1) In the trial,
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, active,
autoantibody-positive SLE while receiving standard therapy.(1,2)

 

SLE is a debilitating autoimmune condition impacting over 3.4 million people
globally.(3) It primarily affects women and can cause pain, rashes, fatigue,
swelling in joints and fevers.(4-8) In Europe, people with SLE have a two to
three times increased risk of death compared to the overall population.(9)
While oral corticosteroids (OCS) 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.(10-12)

 

Professor Thomas Dörner, Rheumatologist and Professor of Rheumatology and
Hemostaseology at Charité University Hospital, Berlin, Germany and
investigator of the TULIP-SC trial, said: "EU approval of anifrolumab in a
self-administered pre-filled pen is fantastic news for people living with
systemic lupus erythematosus as clinicians now have the potential to reach a
wider group of patients with this important medicine, which has been shown to
significantly reduce disease activity and the risk of organ damage. Lupus has
historically been overlooked, but with treatment recommendations now aiming
for disease remission with earlier use of biologics and less reliance on oral
corticosteroids, we're beginning to see real momentum in delivering higher
standards of care."

 

Jeanette Andersen, Chair of Lupus Europe, said: "Lupus is a devastating
disease that primarily impacts young women and is associated with painful
symptoms and a substantial impact on daily life. Anifrolumab has been a
much-needed innovation in systemic lupus erythematosus and at‑home
administration now offers patients a more flexible and convenient option."

 

Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit,
AstraZeneca, said: "We are committed to improving lupus care and since launch,
Saphnelo IV infusion has transformed outcomes for tens of thousands of people
living with systemic lupus erythematosus. With approximately 70% of SLE
patients on biologics in Europe using a subcutaneous self-administration
option, today's approval means we can now offer the clinically meaningful
benefits of Saphnelo while expanding patient choice in how and where they
receive treatment."

 

The safety profile of Saphnelo observed in the interim analysis
(https://www.astrazeneca.com/media-centre/press-releases/2025/saphnelo-met-primary-endpoint-in-tulip-sc.html)
of the TULIP-SC trial was consistent with the known clinical profile of the
medicine administered as an intravenous (IV) infusion.(13-15) The TULIP-SC
interim results were presented during the American College of Rheumatology
(ACR) Convergence 2025 annual meeting and will be published in a forthcoming
medical journal.

 

Subcutaneous administration of Saphnelo is under regulatory review in several
other countries around the world including the US and Japan. Saphnelo IV
infusion is approved for the treatment of moderate to severe SLE in more than
70 countries worldwide including the US, EU and Japan, with regulatory
reviews ongoing in other countries. To date, more than 40,000 patients
globally have been treated with Saphnelo.(16)

 
Notes

 

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 AstraZeneca will pay BMS a low to mid-teens
royalty for sales dependent on geography.

 

Systemic lupus erythematosus

SLE is a chronic and complex autoimmune disease in which the immune system
attacks healthy tissue in the body.(4) 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.(11,17) Even a small reduction in
daily oral corticosteroid use (for example 1 mg/day) can lower the risk of
organ damage.(18) Recent updates to clinical guidelines elevate the importance
of treating to target remission or low disease activity and minimising the use
of oral corticosteroids.(6,7)

 

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, active, autoantibody-positive SLE while
receiving standard therapy (oral corticosteroids, antimalarial, and/or
immunosuppressants).(19)

 

The reduction of disease activity was measured using the British Isles Lupus
Assessment Group based Composite Lupus Assessment (BICLA) at week 52.(19) The
BICLA requires improvement in all organs with disease activity at baseline
with no new flares.(19)

 

Participants (367) were randomised 1:1 to receive 120mg subcutaneous dose of
anifrolumab or placebo administered via a pre-filled, single-use syringe.(19)
A planned interim analysis was conducted when the first 220 participants
reached week 52.(19) The trial also included an open-label extension period of
52 weeks for participants who completed the 52-week treatment period.(19)

 

Saphnelo subcutaneous administration
Saphnelo will be available for subcutaneous self-administration via a
once-weekly 120mg pre-filled pen.  Since 2021, Saphnelo has been available
in an IV infusion administered by healthcare professionals in a hospital or
clinic setting. Subcutaneous administration offers patients the choice to
self-administer treatment outside of the clinic and 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.(15,20) Type I IFNs, such as IFN-alpha, IFN-beta and
IFN-kappa, are cytokines involved in regulating the inflammatory pathways
implicated in SLE.(21-26)

 

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.(27,28) 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.(29)

 

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.(30-33)

 

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/Nasdaq: 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

For details on how to contact the Investor Relations Team, please click here
(https://www.astrazeneca.com/investor-relations.html#Contacts) . For Media
contacts, click here (https://www.astrazeneca.com/media-centre/contacts.html)
.

 

References

1.   AstraZeneca. Saphnelo self-administration TULIP-SC Phase III trial
meets primary endpoint in patients with systemic lupus erythematosus based on
an interim analysis. Available at: Saphnelo self-administration TULIP-SC Phase
III trial meets primary endpoint in patients with systemic lupus erythematosus
based on an interim analysis
(https://www.astrazeneca.com/media-centre/press-releases/2025/saphnelo-met-primary-endpoint-in-tulip-sc.html)
. [Last accessed: December 2025].

2.   Furie R, et al. What does it mean to be a British Isles Lupus
Assessment group-based composite lupus assessment responder? Post hoc analysis
of two phase III trials. Arthritis Rheumatol. 2021;73:2059-2068.

3.   Tian J, et al. Global epidemiology of systemic lupus erythematosus: a
comprehensive systematic analysis and modelling study. Ann Rheum Dis.
2023;82(3):351-356.

4.   Bruce IN, et al. Factors associated with damage accrual in patients
with systemic lupus erythematosus: results from the systemic lupus
international collaborating Clinics (SLICC) inception cohort. Ann Rheum Dis.
2015;74:1706-1713.

5.   Guéry JC. Why is systemic lupus erythematosus more common in women?
Joint Bone Spine. 2019;86(3):297-299.

6.   American College of Rheumatology. 2025 American College of Rheumatology
(ACR) guideline for the treatment of systemic lupus erythematosus (SLE).
Available at: lupus-guideline-sle-2025.pdf
(https://assets.contentstack.io/v3/assets/bltee37abb6b278ab2c/bltdf97323a3723de0f/lupus-guideline-sle-2025.pdf)
. [Last accessed: December 2025].

7.   Fanouriakis A, et al. EULAR recommendations for the management of
systemic lupus erythematosus: 2023 update. Ann Rheum Dis. 2024;83:15-29.

8.   Kaul A, et al. Systemic lupus erythematosus. Nat Rev Dis Primers.
2016;2:16039.

9.   Barber MRW, et al. Global epidemiology of systemic lupus erythematosus.
Nat Rev Rheumatol. 2021;17(9):515-532.

10.  Apostolopoulos D and Morand EF. It hasn't gone away: the problem of
glucocorticoid use in lupus remains. Rheumatology (Oxford). 2017;56(Suppl
1):i114-22.

11.  Ji L, et al. Low-dose glucocorticoids should be withdrawn or continued
in systemic lupus erythematosus? A systematic review and meta-analysis on risk
of flare and damage accrual. Rheumatology. 2021;60:5517-26.

12.  Lateef A and Petri M. Unmet medical needs in systemic lupus
erythematosus. Arthritis Res Ther. 2012;14(Suppl 4):S4.

13.  Morand E, et al. Trial of anifrolumab in active systemic lupus
erythematosus. N Engl J Med. 2020;382(3):211-221.

14.  Furie R, et al. Type I interferon inhibitor anifrolumab in active
systemic lupus erythematosus (TULIP-1): a randomised, controlled, phase 3
trial. Lancet Rheumatol. 2019;1(4):e208-e219.

15.  Furie R, et al. Anifrolumab, an anti-interferon‐α receptor monoclonal
antibody, in moderate‐to‐severe systemic lupus erythematosus. Arthritis
Rheumatol. 2017;69(2):376-386.

16.  AstraZeneca data on file. 2025. REF-290598.

17.  Murimi-Worstell IB, et al. Association between organ damage and
mortality in systemic lupus erythematosus: a systematic review and
meta-analysis. BMJ Open. 2020;10:e031850.

18.  Katsumata Y et al. Risk of flare and damage accrual after tapering
glucocorticoids in modified serologically active clinically quiescent patients
with systemic lupus erythematosus: a multinational observational cohort study.
Ann Rheum Dis. 2024;83:998-1005.

19.  Clinicaltrials.gov Subcutaneous Anifrolumab in Adult Patients With
Systemic Lupus Erythematosus (Tulip-SC). Available at:
https://clinicaltrials.gov/study/NCT04877691
(https://clinicaltrials.gov/study/NCT04877691) . [Last accessed: December
2025].

20.  Riggs JM, et al. Characterisation of anifrolumab, a fully human
anti-interferon receptor antagonist antibody for the treatment of systemic
lupus erythematosus. Lupus Sci Med. 2018;5(1):e000261.

21.  Lauwerys BR, et al. Type I interferon blockade in systemic lupus
erythematosus: where do we stand? Rheumatology. 2014;53(8):1369-1376.

22.  Sarkar MK, et al. Photosensitivity and type I IFN responses in cutaneous
lupus are driven by epidermal-derived interferon kappa. Ann Rheum Dis.
2018;77(11):1653-1664.

23.  Jefferies CA. Regulating IRFs in IFN driven disease. Front Immunol.
2019;10:325.

24.  Mai L, et al. The baseline interferon signature predicts disease
severity over the subsequent 5 years in systemic lupus erythematosus.
Arthritis Res Ther. 2021;23(1):29.

25.  López de Padilla CM, et al. The type I interferons: basic concepts and
clinical relevance in immune-mediated inflammatory diseases. Gene.
2016;576(101):14-21.

26.  Rönnblom L, et al. Interferon pathway in SLE: one key to unlocking the
mystery of the disease. Lupus Sci Med. 2019;6(1):e000270.

27.  Mosca M, et al. Attainment of LLDAS and DORIS remission during
anifrolumab treatment: interim results from a multinational, observational,
post-launch study of treatment effectiveness in the real world. Ann Rheum Dis.
2025. 84(1):168-169.

28.  Morand EF, et al. LLDAS and remission attainment with anifrolumab
treatment in patients with systemic lupus erythematosus: results from the
TULIP and long-term extension randomised controlled trials. Ann Rheum Dis.
2025; 84(5): 777-778.

29.  Vollenhoven R, et al. 2021 DORIS definition of remission in SLE: final
recommendations from an international task force. Lupus Science &
Medicine. 2021; 8: e000538. doi:10.1136/ lupus-2021-000538.

30.  Clinicaltrials.gov. A 2-stage, Phase III Study to Investigate the
Efficacy and Safety of Anifrolumab in Adults with Chronic and/ or Subacute
Cutaneous Lupus Erythematosus (LAVENDER). Available at:
https://clinicaltrials.gov/study/NCT06015737
(https://clinicaltrials.gov/study/NCT06015737) . [Last accessed: December
2025].

31.  Clinicaltrials.gov. A Study to Investigate the Efficacy and Safety of
Anifrolumab Administered as Subcutaneous Injection and Added to Standard of
Care Compared with Placebo Added to Standard of Care in Adult Participants
with Idiopathic Inflammatory Myopathies (Polymyositis and Dermatomyositis)
(JASMINE). Available at: https://clinicaltrials.gov/study/NCT06455449
(https://clinicaltrials.gov/study/NCT06455449) . [Last accessed: December
2025].

32.  Clinicaltrials.gov. Determine Effectiveness of Anifrolumab In SYstemic
Sclerosis (DAISY). Available at: https://clinicaltrials.gov/study/NCT05925803
(https://clinicaltrials.gov/study/NCT05925803) . [Last accessed: December
2025].

33.  ClinicalTrials.gov. Phase 3 Study of Anifrolumab in Adult Patients with
Active Proliferative Lupus Nephritis (IRIS). Available at:
https://www.clinicaltrials.gov/ct2/show/NCT05138133
(https://www.clinicaltrials.gov/ct2/show/NCT05138133) . [Last accessed:
December 2025].

 

 

Matthew Bowden

Company Secretary

AstraZeneca PLC

 

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  MSCUVVBRVBUUAAA



            Copyright 2019 Regulatory News Service, all rights reserved