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 April 2026
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.
Saphnelo
self-administration approved in the US
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 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 and Japan 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
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 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: April
2026].
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(11):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. The Rheumatologist. SLE Is a
leading cause of death among women. Available
at: https://www.the-rheumatologist.org/article/sle-is-a-leading-cause-of-death-among-women.
[Last accessed: April 2026].
7. Izmirly PM, et al. Prevalence of
Systemic Lupus Erythematosus in the United States: Estimates From a
Meta-Analysis of the Centers for Disease Control and Prevention
National Lupus Registries. Arthritis
Rheumatol.
2021;73(6):991-996.
8. 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-i122.
9. 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.
10. Lateef A and Petri M. Unmet medical
needs in systemic lupus erythematosus. Arthritis Res
Ther. 2012;14(Suppl
4):S4.
11. 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: April 2026].
12. Fanouriakis A, et al. EULAR
recommendations for the management of systemic lupus erythematosus:
2023 update. Ann Rheum
Dis.
2024;83(1):15-29.
13.
AstraZeneca data on file. 2025. REF-290598.
14. 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.
15. 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.
16. 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.
17. Kaul A, et al. Systemic lupus
erythematosus. Nat Rev Dis
Primers.
2016;2:16039.
18. 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.
19. 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.
20. 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.
21. 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.
22. 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.
23. Murimi-Worstell IB, et al.:
Healthcare utilization and costs of systemic lupus
erythematosus by disease sever- ity in the United
States. J Rheumatol 2021;
48: 385-93.
24. 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.
25. Clinicaltrials.gov. Subcutaneous
Anifrolumab in Adult Patients With Systemic Lupus Erythematosus
(Tulip SC). Available at: https://clinicaltrials.gov/study/NCT04877691.
[Last accessed: April 2026].
26. Manzi
S, et al. Efficacy and Safety of
Subcutaneous Anifrolumab in Systemic Lupus
Erythematosus: the Randomized, Phase 3, TULIP-SC
Study. Arthritis Rheumatol. 2025. doi:
10.1002/art.70041.
27. 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.
28. Lauwerys BR, et al. Type I
interferon blockade in systemic lupus erythematosus: where do we
stand? Rheumatology.
2014;53(8):1369-1376.
29. 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.
30. Jefferies CA. Regulating IRFs in
IFN driven disease. Front
Immunol.
2019;10:325.
31. 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.
32. 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.
33. Rönnblom L, et al.
Interferon pathway in SLE: one key to unlocking the mystery of the
disease. Lupus Sci
Med.
2019;6(1):e000270.
34. 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.
35. 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: April 2026].
36. 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: April 2026].
37. Clinicaltrials.gov. Determine
Effectiveness of Anifrolumab in Systemic Sclerosis (DAISY).
Available at: https://clinicaltrials.gov/study/NCT05925803.
[Last accessed: April 2026].
38. 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: April 2026].
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: 27 April 2026
|
|
By: /s/
Matthew Bowden
|
|
|
Name:
Matthew Bowden
|
|
|
Title:
Company Secretary
|
