REG - AstraZeneca PLC - Positive CHMP opinion for subcutaneous Saphnelo

AstraZenecaAnnouncement

Today 07:00

For best results when printing this announcement, please click on link below:
https://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20251020:nRST9144Da&default-theme=true

RNS Number : 9144D  AstraZeneca PLC  20 October 2025

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 (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: 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‐α 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
(https://assets.contentstack.io/v3/assets/bltee37abb6b278ab2c/bltec93920aad624e33/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
(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
(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
(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
(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
(https://www.clinicaltrials.gov/ct2/show/NCT05138133) . [Last accessed:
October 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  MSCPKOBNABDDKKD



            Copyright 2019 Regulatory News Service, all rights reserved