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RNS Number : 4829R  AstraZeneca PLC  03 February 2026

3 February 2026

Update on US regulatory review of Saphnelo subcutaneous administration in
systemic lupus erythematosus

The US Food and Drug Administration (FDA) issued a complete response letter
(CRL) regarding the Biologics License Application (BLA) for Saphnelo
(anifrolumab) for subcutaneous administration in adult patients with systemic
lupus erythematosus (SLE). AstraZeneca subsequently provided the information
requested in the CRL and is committed to working with the FDA to progress the
application as quickly as possible.

 

A decision from the FDA on the updated application for Saphnelo SC is expected
in the first half of 2026. Intravenous (IV) Saphnelo remains commercially
available.

 

The original BLA submitted to the FDA by AstraZeneca was based on a planned
interim analysis of the Phase III TULIP-SC trial evaluating the subcutaneous
administration of Saphnelo, which met the primary endpoint. The safety profile
observed in the TULIP-SC trial was consistent with the known clinical profile
of Saphnelo administered as an intravenous (IV) infusion.(1-4)

( )

In December 2025, AstraZeneca announced
(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)
the approval of Saphnelo in the European Union (EU) for subcutaneous
administration in adult patients with moderate to severe SLE. Since then, the
full analysis of the TULIP-SC trial also demonstrated the subcutaneous
administration of Saphnelo met the primary endpoint of reduction in disease
activity. These results were published in Arthritis & Rheumatology
(https://acrjournals.onlinelibrary.wiley.com/doi/10.1002/art.70041) in January
2026.

 

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. To
date, more than 40,000 patients globally have been treated with Saphnelo.(5)

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, updated in
2025, AstraZeneca will pay BMS a mid-teens royalty for sales in the
US. 

 

Systemic lupus erythematosus

SLE is an autoimmune disease in which the immune system attacks healthy tissue
in the body.(6) 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.(6-9)

( )

Over 3.4 million people globally are affected by SLE.(10) Living with SLE can
be painful, debilitating, and have a profound impact on patients' mental and
financial wellbeing.(9,11-15) 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.(11,16) Even a small reduction in
daily steroid use (for example 1mg/day) can lower the risk of organ
damage.(17)

 

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).(18)

 

The reduction of disease activity was measured using the British Isles Lupus
Assessment Group based Composite Lupus Assessment (BICLA) at week 52.(18) The
BICLA requires improvement in all organs with disease activity at baseline
with no new flares.(18)

 

Participants (367) were randomised 1:1 to receive 120mg subcutaneous dose of
anifrolumab or placebo administered via a pre-filled, single-use syringe.(18)
A planned interim analysis was conducted when the first 220 participants
reached week 52.(18) The trial also includes an open-label extension period of
52 weeks for participants who completed the 52-week treatment period.(18)

 

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.(2,19) Type I IFNs, such as IFN-alpha, IFN-beta and
IFN-kappa, are cytokines involved in regulating the inflammatory pathways
implicated in SLE.(20-25)

 

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.(26,27) 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.(28)

 

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.(29-32 )

 

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

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: February 2026].

2.   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.

3.   Morand EF, et al. Trial of Anifrolumab in Active Systemic Lupus
Erythematosus. N Engl J Med. 2020;382(3):211-221.

4.   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.

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

6.   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(9):1706-1713.

7.   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: February 2026].

8.   Fanouriakis A, et al. EULAR recommendations for the management of
systemic lupus erythematosus: 2023 update. Ann Rheum Dis. 2024;83(1):15-29.

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

10.  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.

11.  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(5):e031850.

12.  Primavera D, et al. Quality of Life in Systemic Lupus Erythematosus and
Other Chronic Diseases: Highlighting the Amplified Impact of Depressive
Episodes. Healthcare. 2024;12:233. 25.

13.  Liu X, et al. Mental health conditions in patients with systemic lupus
erythematosus: a systematic review and meta-analysis. Rheumatology (Oxford).
2024;63:3234-3242.

14.  Leung J, et al. "…Not Having the Real Support That We Need": Patients'
Experiences With Ambiguity of Systemic Lupus Erythematosus and Erosion of
Social Support. ACR Open Rheumatol. 2019;1:135-144.

15.  Elefante E, et al. Impact of disease activity patterns on health-related
quality of life (HRQoL) in patients with systemic lupus erythematosus (SLE).
Lupus Sci Med. 2024;11:e001202.

16.  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(12):5517-5526.

17.  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(8):998-1005.

18.  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: February
2026].

19.  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.

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

21.  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.

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

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

24.  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.

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

26.  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.

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.  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.

29.  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:  February
2026].

30.  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: February
2026].

31.  Clinicaltrials.gov. Determine Effectiveness of Anifrolumab in Systemic
Sclerosis (DAISY). Available at: https://clinicaltrials.gov/study/NCT05925803
(https://clinicaltrials.gov/study/NCT05925803) . [Last accessed: February
2026].

32.  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:
February 2026].

 

 

Matthew Bowden

Company Secretary

AstraZeneca PLC

 

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