TIDMAZN
RNS Number : 1194W
AstraZeneca PLC
20 December 2021
20 December 2021 07:00 GMT
Saphnelo recommended for approval in the EU by CHMP for the
treatment of patients with systemic lupus erythematosus
Saphnelo is a first-in-class type I interferon receptor antibody
shown to reduce overall disease activity in patients with systemic
lupus erythematosus
AstraZeneca's Saphnelo (anifrolumab) has been recommended for
marketing authorisation in the European Union (EU) as an add-on
therapy for the treatment of adult patients with moderate to
severe, active autoantibody-positive systemic lupus erythematosus
(SLE), despite receiving standard therapy. SLE is a complex
autoimmune condition that can affect any organ, and people often
experience inadequate disease control, long-term organ damage and
poor health-related quality of life. If approved, Saphnelo would be
the first new treatment for SLE in Europe in more than a
decade.(1)
The Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency based its positive opinion on results
from the Saphnelo clinical development programme, including the
TULIP Phase III trials and the MUSE Phase II trial. In these
trials, more patients treated with Saphnelo experienced a reduction
in overall disease activity across organ systems and achieved
sustained reduction in oral corticosteroid (OCS) use compared to
placebo, with both groups receiving standard therapy.(2,3,4)
Ian Bruce, Professor of Rheumatology at the University of
Manchester, UK, and steering committee chair for the Saphnelo SLE
clinical development programme, said, "Systemic lupus erythematosus
is a complex and heterogeneous disease that can have a debilitating
impact on a person's quality of life. We need new treatments that
are effective in reducing underlying disease activity for patients,
particularly those who require higher doses of oral
corticosteroids, which themselves can be damaging in the long-term.
The anifrolumab clinical programme has provided compelling evidence
that this medicine has the potential to be an important new option
for patients."
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&D, AstraZeneca, said: "Saphnelo is a ground-breaking
first-in-class medicine and offers physicians and patients a new
way of treating systemic lupus erythematosus by targeting the type
I interferon receptor, which is known to play a central role in
lupus disease pathophysiology. This positive recommendation from
the CHMP brings us one step closer to providing a much-needed new
treatment option to improve outcomes for patients in Europe."
The adverse reactions that occurred more frequently in patients
who received Saphnelo in the three clinical trials included upper
respiratory tract infection, bronchitis, infusion-related reactions
and herpes zoster.(2,3,4)
Saphnelo was recently approved in the US , Japan and Canada for
the treatment of SLE, and regulatory reviews are ongoing in
additional countries. The Phase III trial in SLE using subcutaneous
delivery has been initiated and additional Phase III trials are
planned for lupus nephritis, cutaneous lupus erythematosus and
myositis.
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 an autoimmune disease in which the immune system attacks
healthy tissue in the body.(5) 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) There are approximately
250,000 people with SLE in Europe, and most are women diagnosed
between the ages of 15 and 45.(7,8) More than 50% of patients with
SLE develop permanent organ damage, caused by the disease or
existing treatments, which exacerbates symptoms and increases the
risk of mortality.(9,10) At least five million people worldwide
have a form of lupus.(11)
TULIP-1, TULIP-2 and MUSE
All three trials for Saphnelo (TULIP-1, TULIP-2 and MUSE) were
randomised, double-blinded, placebo-controlled trials in patients
with moderate to severe SLE who were receiving standard therapy.
Standard therapy included at least one of the following: OCS,
antimalarials and immunosuppressants (methotrexate, azathioprine or
mycophenolate mofetil).(2,3,4)
The pivotal TULIP (Treatment of Uncontrolled Lupus via the
Interferon Pathway) Phase III programme included two trials,
TULIP-1 and TULIP-2, that evaluated the efficacy and safety of
Saphnelo versus placebo.(2,3) TULIP-2 demonstrated superiority
across multiple efficacy endpoints versus placebo with both arms
receiving standard therapy. In the trial, 362 eligible patients
were randomised (1:1) and received a fixed-dose intravenous
infusion of 300mg Saphnelo or placebo every four weeks. TULIP-2
assessed the effect of Saphnelo in reducing disease activity as
measured by the BILAG-Based Composite Lupus Assessment (BICLA)
scale.(2) In TULIP-1, 457 eligible patients were randomised (1:2:2)
and received a fixed-dose intravenous infusion of 150mg Saphnelo,
300mg Saphnelo or placebo every four weeks, in addition to standard
therapy. The trial did not meet its primary endpoint based on the
SLE Responder Index 4 (SRI4) composite measure.(3)
The MUSE Phase II trial evaluated the efficacy and safety of two
doses of Saphnelo versus placebo. In MUSE, 305 adults were
randomised and received a fixed-dose intravenous infusion of 300mg
Saphnelo, 1,000mg Saphnelo or placebo every four weeks, in addition
to standard therapy, for 48 weeks. The trial showed improvement
versus placebo across multiple efficacy endpoints with both arms
receiving standard therapy.(4)
Results from the TULIP-2 Phase III trial were published in The
New England Journal of Medicine in January 2020, results from the
TULIP-1 Phase III trial were published in The Lancet Rheumatology
in December 2019 and results from the MUSE Phase II trial were
published in Arthritis & Rheumatology in November 2016.
In SLE, along with the pivotal TULIP Phase III programme,
Saphnelo continues to be evaluated in a long-term extension Phase
III trial and a Phase III trial assessing subcutaneous
delivery.(12,13) In addition, AstraZeneca is exploring the
potential of Saphnelo in a variety of diseases in which type I
interferon (type I IFN) plays a key role, including lupus
nephritis, cutaneous lupus erythematosus and myositis.
Saphnelo
Saphnelo (anifrolumab) is a fully human monoclonal antibody that
binds to subunit 1 of the type I IFN receptor, blocking the
activity of type I IFN.(4) Type I IFNs, such as IFN-alpha, IFN-beta
and IFN-kappa, are cytokines involved in regulating the
inflammatory pathways implicated in SLE.(14,15,16,17,18,19) The
majority of adults with SLE have increased type I IFN signalling,
which is associated with increased disease activity and
severity.(14,20)
AstraZeneca in Respiratory & Immunology
Respiratory & Immunology, part of BioPharmaceuticals, is one
of AstraZeneca's main disease areas and is a key growth driver for
the Company.
AstraZeneca is an established leader in respiratory care with a
50-year heritage. The Company aims to transform the treatment of
asthma and chronic obstructive pulmonary disease (COPD) by focusing
on earlier biology-led treatment, eliminating preventable asthma
attacks and removing COPD as a top-three leading cause of death.
The Company's early respiratory research is focused on emerging
science involving immune mechanisms, lung damage and abnormal
cell-repair processes in disease and neuronal dysfunction.
With common pathways and underlying disease drivers across
respiratory and immunology, AstraZeneca is following the science
from chronic lung diseases to immunology-driven disease areas. The
Company's growing presence in immunology is focused on five mid- to
late-stage franchises with multi-disease potential, in areas
including rheumatology (including SLE), dermatology,
gastroenterology, and systemic eosinophilic-driven diseases.
AstraZeneca's ambition in Respiratory & Immunology is to
achieve disease modification and durable remission for millions of
patients worldwide.
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 operates in over
100 countries and its innovative medicines are used by millions of
patients worldwide. Please visit astrazeneca.com and follow the
Company on Twitter @AstraZeneca .
Contacts
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References
1. European Medicines Agency. Benlysta. Available online.
Accessed December 2021.
2. Morand E, et al. Trial of Anifrolumab in Active Systemic
Lupus Erythematosus. N Engl J Med. 2020;382(3):211-221. Accessed
December 2021.
3. 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.
Accessed December 2021.
4. Furie R, et al. Anifrolumab, an Anti-Interferon --
<ALPHA> Receptor Monoclonal Antibody, in Moderate -- to --
Severe Systemic Lupus Erythematosus. Arthritis Rheumatol.
2017;69(2):376-386. Accessed December 2021.
5. The Lupus Foundation of America. What is Lupus? Available
online. Accessed December 2021.
6. American College of Rheumatology. Guidelines for referral and
management of systemic lupus erythematosus in adults. Arthritis
Rheumatol. 1999;42:1785-1796. Accessed December 2021.
7. Cornet A, et al. Living with systemic lupus erythematosus in
2020: a European patient survey. Lupus Sci Med. 2021;8:e000469.
Accessed December 2021.
8. Lupus Europe. FAQs. Accessed December 2021.
9. 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. Accessed
December 2021.
10. Segura BT, et al. Damage accrual and mortality over
long-term follow-up in 300 patients with systemic lupus
erythematosus in a multi-ethnic British cohort. Rheumatol.
2020;59(3):524-533. Accessed December 2021.
11. The Lupus Foundation of America. Lupus facts and statistics.
Available online. Accessed December 2021.
12. ClinicalTrials.gov. Long Term Safety of Anifrolumab in Adult
Subjects With Active Systemic Lupus Erythematosus (TULIP SLE LTE).
NCT Identifier: NCT02794285. Accessed December 2021.
13. ClinicalTrials.gov. Subcutaneous Anifrolumab in Adult
Patients With Systemic Lupus Erythematosus (Tulip SC). NCT
Identifier: NCT04877691. Accessed December 2021.
14. Lauwerys BR, et al. Type I interferon blockade in systemic
lupus erythematosus: where do we stand? Rheumatol.
2014;53:1369-1376. Accessed December 2021.
15. Sarkar MK, et al. Photosensitivity and type I IFN responses
in cutaneous lupus are driven by epidermal-derived interferon
kappa. Ann Rheum Dis. 2018;77:1653-1664. Accessed December
2021.
16. Jefferies CA. Regulating IRFs in IFN Driven Disease. Front
Immunol. 2019;10:325. Accessed December 2021.
17. Mai L, et al. The baseline interferon signature predicts
disease severity over the subsequent 5 years in systemic lupus
erythematosus. Arthritis Res Ther. 2021;23:29. Accessed December
2021.
18. 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. Accessed December 2021.
19. Rönnblom L, et al. Interferon pathway in SLE: one key to
unlocking the mystery of the disease. Lupus Sci Med.
2019;6(1):e000270. Accessed December 2021.
20. Crow MK. Type I Interferon in the Pathogenesis of Lupus. J
Immunol. 2014;192(12):5459-5468. Accessed December 2021.
Adrian Kemp
Company Secretary
AstraZeneca PLC
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