FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of December 2025
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F X Form 40-F __
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(1):
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(7): ______
Indicate
by check mark whether the registrant by furnishing the information
contained in this Form is also thereby furnishing the information
to the Commission pursuant to Rule 12g3-2(b) under the Securities
Exchange Act of 1934.
Yes __
No X
If
“Yes” is marked, indicate below the file number
assigned to the Registrant in connection with Rule 12g3-2(b):
82-_____________
AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Subcutaneous Saphnelo approved in EU
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 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 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
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 and
follow the Company on Social Media @AstraZeneca.
Contacts
For details on how to contact the Investor Relations Team, please
click here.
For Media contacts, click here.
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. [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.
[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‐a
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.
[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.
[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.
[Last accessed: December 2025].
32. Clinicaltrials.gov.
Determine Effectiveness of Anifrolumab In SYstemic Sclerosis
(DAISY). Available at: 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.
[Last accessed: December 2025].
Matthew Bowden
Company Secretary
AstraZeneca PLC
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
Date: 16 December 2025
|
|
By: /s/
Matthew Bowden
|
|
|
Name:
Matthew Bowden
|
|
|
Title:
Company Secretary
|
