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 October 2025
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
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United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Positive CHMP opinion for subcutaneous Saphnelo
20 October 2025
Saphnelo subcutaneous
self-administration recommended for approval in EU by CHMP for
systemic lupus erythematosus
Recommendation based on TULIP-SC Phase III trial results showing
first-in-class Saphnelo reduced disease activity via once-weekly
subcutaneous administration
AstraZeneca's Saphnelo (anifrolumab) has been recommended for
approval in the European Union (EU) as a self-administered
once-weekly pre-filled pen for adult patients with systemic lupus
erythematosus (SLE) on top of standard therapy.
The Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency based its positive opinion on
interim 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, active,
autoantibody-positive SLE while receiving standard
therapy.1,2 The
safety profile observed was consistent with the known clinical
profile of Saphnelo administered as an intravenous (IV)
infusion.3-5
Professor Thomas Dörner, Rheumatologist and Professor of
Rheumatology and Hemostaseology at Charité University
Hospital, Berlin, Germany and investigator of the TULIP-SC
trial said: "The positive recommendation for the subcutaneous
administration of anifrolumab in the EU is highly
encouraging for people living with systemic lupus erythematosus, as
many still rely on oral corticosteroids, which carry significant
side effects and are known to accelerate damage and functional
impairment. With the latest treatment recommendations for SLE
now placing increased importance on the use of biologics and
earlier intervention to target remission while minimising
steroids, a subcutaneous form of anifrolumab has the potential
to offer broader access for patients."
Ruud Dobber, Executive Vice President, BioPharmaceuticals Business
Unit, AstraZeneca, said: "Saphnelo IV infusion has already helped transform
outcomes for many patients with systemic lupus erythematosus. With
this positive CHMP recommendation, we're one step closer to
offering the clinically meaningful benefits
of Saphnelo to more people in a convenient, once-weekly
self-administration option. We are also advancing a robust
development programme to explore Saphnelo's potential in other diseases where type 1
interferon plays a central role, including cutaneous lupus
erythematosus, lupus nephritis, myositis and systemic
sclerosis."
SLE is a debilitating autoimmune condition impacting more than 3.4
million people globally.6 It
primarily affects women and can cause pain, rashes, fatigue,
swelling in joints and fevers.7-11 In
Europe, people with SLE have a two to three times increased risk of
death compared to the overall population.12 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.13-15 Approximately
70% of people in Europe who are on biologic therapy for SLE are
already receiving a subcutaneous administration
option.16
Subcutaneous administration of Saphnelo is 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, EU and Japan, with regulatory
reviews ongoing in other countries. To date, more than 40,000
patients globally have been treated with Saphnelo.17
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.7 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.14,18 Even
a small reduction in daily oral corticosteroid use (for example
1mg/day) can lower the risk of organ damage.19 Recent
updates to clinical guidelines elevate the importance of treating
to target remission or low disease activity and minimising the use
of oral corticosteroids.9,10
EULAR treatment recommendations
The recently updated international SLE treatment recommendations
from the European Alliance of Associations for Rheumatology (EULAR)
emphasise the need for prompt initiation of treatment aiming at
remission, which is associated with improved clinical outcomes
including reduced organ damage, fewer flares, reduced
hospitalisation, reduced mortality and improved health-related
quality of life.10 The
revised SLE treatment recommendations advise an OCS-sparing
approach (a threshold of 5mg per day or less) to significantly
reduce disease progression and improve quality of life for
patients.10
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).20
The reduction of disease activity was measured using the British
Isles Lupus Assessment Group based Composite Lupus Assessment
(BICLA) at week 52.20 The
BICLA requires improvement in all organs with disease activity at
baseline with no new flares.20
Participants (367) were randomised 1:1 to receive 120mg
subcutaneous dose of anifrolumab or placebo administered via a
pre-filled, single-use syringe.20 A
planned interim analysis was conducted when the first 220
participants reached week 52.20 The
trial also includes an open-label extension period of 52 weeks for
participants who completed the 52-week treatment
period.20
Saphnelo subcutaneous
administration
Since 2021, Saphnelo has been available in an IV infusion
administered by healthcare professionals in a hospital or clinic
setting. The potential option for a subcutaneous
administration with Saphnelo will
enable patients and caregivers to administer the medicine at home
or in clinic 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.5,21 Type
I IFNs, such as IFN-alpha, IFN-beta and IFN-kappa, are cytokines
involved in regulating the inflammatory pathways implicated in
SLE.22-27
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.28-31
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: October
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. Morand E, 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. 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.
6. 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.
7. 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.
8. Guéry JC. Why is systemic
lupus erythematosus more common in women?. Joint Bone
Spine.
2019;86(3):297-299.
9. American College
of Rheumatology. 2025 American College of Rheumatology (ACR)
guideline for the treatment of systemic lupus erythematosus (SLE).
Available at: sle-guideline-summary-2025.pdf.
[Last accessed: October 2025].
10. Fanouriakis A, et
al. EULAR recommendations for the management of
systemic lupus erythematosus: 2023 update. Ann Rheum
Dis.
2024;83:15-29.
11. Kaul A, et al. Systemic lupus
erythematosus. Nat Rev Dis
Primers.
2016;2:16039.
12. Barber MRW, et al. Global epidemiology
of systemic lupus erythematosus. Nat Rev
Rheuatol. 2021;17(9):515-532.
13. 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.
14. 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.
15. Lateef A and Petri M. Unmet
medical needs in systemic lupus
erythematosus. Arthritis Res
Ther.
2012;14(Suppl 4):S4.
16. AstraZeneca data on file.
REF-291165. 2025
17. AstraZeneca data on file.
REF-290598. 2025.
18. 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.
19. 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.
20. Clinicaltrials.gov
Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus
Erythematosus (Tulip-SC). Available at: https://clinicaltrials.gov/study/NCT04877691.
[Last accessed: October 2025].
21. 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.
22. Lauwerys BR, et al. Type I
interferon blockade in systemic lupus erythematosus: where do we
stand? Rheumatology.
2014;53(8):1369-1376.
23. 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.
24. Jefferies CA. Regulating IRFs in IFN
driven disease. Front
Immunol.
2019;10:325.
25. 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.
26. 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.
27. Rönnblom L, et al. Interferon
pathway in SLE: one key to unlocking the mystery of the
disease. Lupus Sci
Med.
2019;6(1):e000270.
28. 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: October 2025].
29. 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: October 2025].
30. Clinicaltrials.gov. Determine
Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY).
Available at: https://clinicaltrials.gov/study/NCT05925803.
[Last accessed: October 2025].
31. 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: October 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.
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AstraZeneca
PLC
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Date: 20 October 2025
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By: /s/
Matthew Bowden
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Name:
Matthew Bowden
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Title:
Company Secretary
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