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 September 2024
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Fasenra recommended for EU approval in EGPA
23 September 2024
Fasenra recommended for approval in the
EU by CHMP for the treatment of eosinophilic granulomatosis with
polyangiitis
New indication supported by the MANDARA trial which showed nearly
60% of patients achieved remission and 41% of patients fully
stopped taking oral corticosteroids
AstraZeneca's Fasenra (benralizumab) has been recommended for
approval in the European Union (EU) as an add-on treatment for
adult patients with relapsing or refractory eosinophilic
granulomatosis with polyangiitis (EGPA). EGPA is a rare,
immune-mediated vasculitis that can result in damage to multiple
organs, and without treatment, can be fatal.1,2
The Committee for Medicinal Products for Human Use
(CHMP) of the European Medicines Agency based its positive
opinion on results from the MANDARA Phase III trial published
in The
New England Journal of Medicine,3 which
compared the efficacy and safety of Fasenra to the only approved EGPA treatment,
mepolizumab, in patients with relapsing or refractory
EGPA.3-5 MANDARA
was the first head-to-head non-inferiority trial of biologics in
patients with EGPA.4,6 Patients
were randomised to receive either a single 30 mg subcutaneous
injection of Fasenra, or three separate 100 mg subcutaneous injections
of mepolizumab every four weeks.3,4
In the trial, nearly 60% of Fasenra-treated patients achieved remission which was
comparable to mepolizumab-treated patients.3 Data
also showed 41% of Fasenra-treated patients fully tapered off oral
corticosteroids (OCS) (vs. 26% in the comparator arm (difference:
16%; 95% CI: 1,31)).3
Bernhard Hellmich, Chair of the Department of Internal Medicine,
Rheumatology, and Immunology at the Medius Klinik Kirchheim,
Teaching Hospital of the University of Tübingen, Co-Director
of the Vasculitis Center Tübingen-Kirchhei, and MANDARA
Principal Investigator said: "People living with EGPA in
Europe often face debilitating symptoms and suffer serious and
long-lasting side effects from treatment with long-term oral
corticosteroids. With its unique mechanism of action that leads to
near complete depletion of eosinophils, Fasenra represents a much-needed potential treatment
option for EGPA patients to help them achieve remission and taper
off steroid therapy."
Ruud Dobber, Executive Vice President, BioPharmaceuticals Business
Unit, AstraZeneca said: "With today's recommendation, the EGPA
community in Europe is one step closer to accessing a new and
convenient treatment option to alleviate some of the impact of this
debilitating disease. With over 15 years of clinical
data, Fasenra is a well-established, leading treatment for
severe eosinophilic asthma, and now has the potential to transform
care for patients with EGPA. Today's news demonstrates the
potential of Fasenra to help patients suffering from eosinophilic
diseases beyond severe asthma."
The safety and tolerability profile for Fasenra in the MANDARA trial was consistent with the
known profile of the medicine.3
Approximately half of patients with EGPA have adult-onset severe
eosinophilic asthma (SEA) and often have sinus and nasal
symptoms.2,7,8 If
approved, Fasenra would be only the second biologic approved
to treat this disease.3,4
Fasenra was recently approved in the US for the treatment
of EGPA9 and
is also approved as an add-on maintenance treatment for severe
eosinophilic asthma (SEA) in more than 80 countries including the
US, Japan, EU and China.10-13 It
is also approved in children and adolescents
ages six and
above in the US and Japan.12
Notes
Eosinophilic granulomatosis with polyangiitis
EGPA, formerly known as Churg-Strauss Syndrome, is a rare,
immune-mediated inflammatory disease that is caused by inflammation
of small to medium-sized blood vessels.1,2 It
is estimated that 118,000 people throughout the world live with
EGPA.14 EGPA
can result in damage to multiple organs, including lungs, upper
airway, skin, heart, gastrointestinal tract and
nerves.2 The
most common symptoms and signs include extreme fatigue, weight
loss, muscle and joint pain, rashes, nerve pain, sinus and nasal
symptoms, and shortness of breath.2,16 Without
treatment, the disease may be fatal.2,15 Almost
half (47%) of patients do not achieve remission with current
treatments.16
There are limited treatment options for EGPA. Patients are often
treated with chronic high-dose OCS and experience recurrent
relapses when attempting to taper off OCS.15,17
MANDARA
MANDARA was a Phase III, randomised, double-blinded,
active-controlled trial, which compared the efficacy and safety
of Fasenra to mepolizumab in adult patients with
relapsing or refractory EGPA.4 In
the trial, 140 patients were randomised 1:1 to receive either a
single 30 mg subcutaneous injection of Fasenra or three separate 100 mg subcutaneous
injections of the active comparator every four
weeks.3
The primary endpoint was the proportion of patients who were in
remission at both weeks 36 and 48.4 Remission
is defined as Birmingham Vasculitis Activity Score (BVAS)=0 and OCS
dose less than or equal to 4 mg/day.4 A
secondary endpoint was the proportion of patients who were able to
fully taper off OCS at weeks 48 through 52.3 The
primary statistical analysis was to demonstrate non-inferiority
of Fasenra versus mepolizumab based on the primary
endpoint.3
Fasenra
Fasenra (benralizumab) is
currently approved in more than 80 countries, including the US, EU,
Japan, and China.10-13 Fasenra has
been prescribed to over 130,000 patients
globally.18
Fasenra is in development
for other diseases including chronic obstructive pulmonary disease,
chronic rhinosinusitis with nasal polyps and hypereosinophilic
syndrome.19-21
Fasenra was developed by
AstraZeneca and is in-licensed from BioWa, Inc., a wholly owned
subsidiary of Kyowa Kirin Co., Ltd.,
Japan.
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. Furuta
S, et
al. Update on eosinophilic
granulomatosis with polyangiitis. Allergol
Int.
2019;68:430-436.
2. American Partnership for
Eosinophilic Disorders. Eosinophilic Granulomatosis with
Polyangiitis (EGPA). Available at: https://apfed.org/about-ead/eosinophilic-granulomatosis-with-polyangiitis/.
[Last accessed: September 2024].
3. Wechsler
ME, et
al. Benralizumab versus
Mepolizumab for Eosinophilic Granulomatosis with
Polyangiitis. N Engl J
Med. 2024;390(10):911-921.
4. Clinicaltrials.gov. Efficacy
and Safety of Benralizumab in EGPA Compared to Mepolizumab.
(MANDARA). Available at: https://classic.clinicaltrials.gov/ct2/show/NCT04157348.
[Last accessed: September 2024].
5. Mepolizumab US prescribing
information. Available from: https://www.fda.gov/files/drugs/published/125526-Mepolizumab-Clinical-PREA.pdf [Last
accessed: September 2024].
6. AstraZeneca plc. MANDARA Phase
III data published in New England Journal of Medicine show
remission is an achievable goal in eosinophilic granulomatosis with
polyangiitis (EGPA) with Fasenra. Available
at: https://www.astrazeneca.com/media-centre/medical-releases/mandara-phase-iii-data-published-new-england-journal-medicine-show-remission-achievable-goal-eosinophilic-granulomatosis-polyangiitis-egpa-fasenra.html.
[Last accessed: September 2024]
7. Cottin V, et al. Respiratory manifestations of eosinophilic
granulomatosis with polyangiitis
(Churg-Strauss). Eur Respir
J.
2016;48:1429-1441.
8. Heaney
L et
al. Eosinophilic and
Noneosinophilic Asthma: An Expert Consensus Framework to
Characterize Phenotypes in a Global Real-Life Severe Asthma
Cohort. Chest. 2021 Sep;160(3):814-830.
9. Fasenra (benralizumab) US prescribing information;
September 2024. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761070s021lbl.pdf [Last
accessed: September 2024]
10. AstraZeneca news release. Available
at: https://www.astrazeneca.com/media-centre/press-releases/2019/fasenra-approved-in-the-us-for-self-administration-in-a-new-pre-filled-auto-injector-the-fasenra-pen-04102019.html#.
[Last accessed: September 2024].
11. AstraZeneca news release. Available
at: https://www.astrazeneca.com/media-centre/press-releases/2019/fasenra-receives-positive-eu-chmp-opinion-for-self-administration-and-the-new-fasenra-pen-a-pre-filled-single-use-auto-injector-01072019.html#.
[Last accessed: September 2024].
12. AstraZeneca Annual Report 2023.
Available at: https://www.astrazeneca.com/content/dam/az/Investor_Relations/annual-report-2023/pdf/AstraZeneca_AR_2023.pdf.
[Last accessed: September 2024].
13. AstraZeneca news release. Fasenra
met the primary endpoint in the MANDARA Phase III trial in
eosinophilic granulomatosis with polyangiitis (EGPA). Available
at: https://www.astrazeneca.com/media-centre/press-releases/2023/fasenra-phase-iii-egpa-trial-met-primary-endpoint.html#:~:text=Positive%20high%2Dlevel%20results%20from,EGPA)%20who%20were%20receiving%20oral.
[Last accessed: September 2024].
14.
AstraZeneca Data on file. 2024. REF- 244520.
15. Baldini C, et al. Clinical
Manifestations and Treatment of Churg-Strauss
Syndrome. Rheum Dis Clin N
Am.
2010;36:527-543.
16. Wechsler
ME, et
al. Mepolizumab or Placebo for
Eosinophilic Granulomatosis with
Polyangiitis. N Engl J
Med. 2017:376;1921-1932.
17. Bell CF, et al. Burden of illness and costs associated with
eosinophilic granulomatosis with polyangiitis: evidence from a
managed care database in the United
States. J
Manag Care Spec Pharm.
2021;27(9):1249-1259.
18. AstraZeneca
data on file. 2024. REF-235794.
19. Clinicaltrials.gov. Efficacy and Safety
of Benralizumab in Moderate to Very Severe Chronic Obstructive
Pulmonary Disease (COPD) With a History of Frequent Exacerbations
(RESOLUTE). Available from: https://clinicaltrials.gov/ct2/show/NCT04053634 [Last
accessed: September 2024].
20. Clinicaltrials.gov. Efficacy and Safety
Study of Benralizumab in Patient With Eosinophilic Chronic
Rhinosinusitis With Nasal Polyps (ORCHID). Available
at: https://clinicaltrials.gov/ct2/show/NCT04157335 [Last
accessed: September 2024].
21. Clinicaltrials.gov. A Phase 3 Study to
Evaluate the Efficacy and Safety of Benralizumab in Patients With
Hypereosinophilic Syndrome (HES) (NATRON). Available
from: https://clinicaltrials.gov/ct2/show/NCT04191304 [Last
accessed: September 2024].
Adrian Kemp
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:
23 September 2024
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By: /s/
Adrian Kemp
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Name:
Adrian Kemp
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Title:
Company Secretary
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