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 approved
in the US for the treatment of adult patients with eosinophilic
granulomatosis with polyangiitis (EGPA).1 EGPA is a rare,
immune-mediated vasculitis that can result in damage to multiple
organs, and without treatment, can be fatal.2,3
The approval by the US Food and Drug Administration (FDA) was
based on positive results from the MANDARA Phase III trial
published in The New England Journal of Medicine,4 which compared
the efficacy and safety of FASENRA to the only approved EGPA
treatment, mepolizumab, in patients with relapsing or refractory
EGPA.4-6 MANDARA was the first head-to-head non-inferiority trial
of biologics in patients with EGPA.5,7 Patients were randomized to
receive either a single 30 mg subcutaneous injection of FASENRA, or
three separate 100 mg subcutaneous injections of mepolizumab every
four weeks.4,5
In the trial, nearly 60% of FASENRA-treated patients achieved
remission which was comparable to mepolizumab-treated patients.4
Data also showed 41% of FASENRA-treated patients fully tapered off
oral corticosteroids (OCS) (vs. 26% in the mepolizumab arm
(difference: 16%; 95% CI: 1,31)).4
Dr. Michael Wechsler, Professor of Medicine and Director of The
Asthma Institute at National Jewish Health, and International
Coordinating Investigator of the MANDARA trial said: “This approval
is great news for patients with EGPA in the US who continue to
suffer from debilitating symptoms. Patients often rely on long-term
oral corticosteroids, which can cause serious and lasting side
effects. Benralizumab is a much-needed treatment option, with data
showing that not only is remission an achievable goal for EGPA
patients, but benralizumab can also help patients taper off steroid
therapy.”
Joyce Kullman, Executive Director, Vasculitis Foundation said:
“This disease has a devastating impact on patients and the quality
of their life, and they need more treatment options. The approval
of another treatment in EGPA is welcome news to the approximately
15,000 patients living in the US with this difficult-to-treat rare
disease.”
Ruud Dobber, Executive Vice President, BioPharmaceuticals
Business Unit, AstraZeneca said: “FASENRA is already well
established for the treatment of severe eosinophilic asthma, and
with this approval, physicians in the US will now be able to offer
an important new, convenient single monthly subcutaneous injection
to their 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.4
Approximately half of patients with EGPA have adult-onset severe
eosinophilic asthma (SEA) and often have sinus and nasal
symptoms.3,8,9 FASENRA is only the second biologic approved to
treat this disease.4,5
FASENRA is currently approved as an add-on maintenance treatment
for SEA in more than 80 countries including the US, Japan, EU, and
China.10-13 It is also approved in children and adolescents ages 6
and above in the US and Japan. The FDA granted Orphan Drug
Designation for FASENRA for EGPA in 2018.14
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS Known hypersensitivity to benralizumab
or excipients.
WARNINGS AND PRECAUTIONS Hypersensitivity
Reactions Hypersensitivity reactions (eg, anaphylaxis,
angioedema, urticaria, rash) have occurred after administration of
FASENRA. These reactions generally occur within hours of
administration, but in some instances have a delayed onset (ie,
days). Discontinue in the event of a hypersensitivity reaction.
Acute Asthma Symptoms or Deteriorating Disease FASENRA
should not be used to treat acute asthma symptoms, acute
exacerbations, or acute bronchospasm.
Reduction of Corticosteroid Dosage Do not discontinue
systemic or inhaled corticosteroids abruptly upon initiation of
therapy with FASENRA. Reductions in corticosteroid dose, if
appropriate, should be gradual and performed under the direct
supervision of a physician. Reduction in corticosteroid dose may be
associated with systemic withdrawal symptoms and/or unmask
conditions previously suppressed by systemic corticosteroid
therapy.
Parasitic (Helminth) Infection It is unknown if FASENRA
will influence a patient’s response against helminth infections.
Treat patients with pre-existing helminth infections before
initiating therapy with FASENRA. If patients become infected while
receiving FASENRA and do not respond to anti-helminth treatment,
discontinue FASENRA until infection resolves.
ADVERSE REACTIONS The most common adverse reactions
(incidence ≥ 5%) include headache and pharyngitis.
Injection site reactions (eg, pain, erythema, pruritus, papule)
occurred at a rate of 2.2% in patients treated with FASENRA
compared with 1.9% in patients treated with placebo in asthma
exacerbation studies.
USE IN SPECIFIC POPULATIONS The data on pregnancy
exposure from the clinical trials are insufficient to inform on
drug-associated risk. Monoclonal antibodies such as benralizumab
are transported across the placenta during the third trimester of
pregnancy; therefore, potential effects on a fetus are likely to be
greater during the third trimester of pregnancy.
INDICATIONS FASENRA is indicated for:
- the add-on maintenance treatment of patients with severe asthma
aged 6 years and older and with an eosinophilic phenotype. FASENRA
is not indicated for the relief of acute bronchospasm or status
asthmaticus
- the treatment of adult patients with eosinophilic
granulomatosis with polyangiitis (EGPA)
Please read accompanying Prescribing
Information, including Patient
Information.
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.2,3 It is estimated that
118,000 people throughout the world live with EGPA and
approximately 15,000 patients living in the US have EGPA.15,16 EGPA
can result in damage to multiple organs, including lungs, upper
airway, skin, heart, gastrointestinal tract and nerves.3 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.3,17 Without treatment, the
disease may be fatal.3,17 Almost half (47%) of patients do not
achieve remission with current treatments.18
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.17,19
MANDARA MANDARA was a Phase III, randomized,
double-blinded, active-controlled trial, which compared the
efficacy and safety of FASENRA to mepolizumab in adult patients
with relapsing or refractory EGPA.5 In the trial, 140 patients were
randomized 1:1 to receive either a single 30mg subcutaneous
injection of FASENRA or three separate 100mg subcutaneous
injections of the active comparator every four weeks.4
The primary endpoint was the proportion of patients who were in
remission at both weeks 36 and 48.5 Remission is defined as
Birmingham Vasculitis Activity Score (BVAS)=0 and OCS dose less
than or equal to 4 mg/day.5 A secondary endpoint was the proportion
of patients who were able to fully taper off OCS at weeks 48
through 52.5 The primary statistical analysis was to demonstrate
non-inferiority of FASENRA versus mepolizumab based on the primary
endpoint.4
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.20
FASENRA is in development for other diseases including chronic
obstructive pulmonary disease, chronic rhinosinusitis with nasal
polyps and hypereosinophilic syndrome.21-23
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 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 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 systemic lupus erythematosus),
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 is a global, science-led
biopharmaceutical company that focuses on the discovery,
development and commercialization of prescription medicines in
Oncology, Rare Diseases and BioPharmaceuticals, including
Cardiovascular, Renal & Metabolism, and Respiratory &
Immunology. Based in Cambridge, UK, AstraZeneca operates in over
125 countries, and its innovative medicines are used by millions of
patients worldwide. For more information, please visit
www.astrazeneca-us.com and follow us on social media
@AstraZeneca.
References
- FASENRA (benralizumab) US prescribing information; September
2024.
- Furuta S, et al. Update on eosinophilic granulomatosis with
polyangiitis. Allergol Int. 2019;68:430-436.
- 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].
- Wechsler ME, et al. Benralizumab versus Mepolizumab for
Eosinophilic Granulomatosis with Polyangiitis. N Engl J Med.
2024;390(10):911-921.
- 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].
- Mepolizumab US prescribing information. Available from:
https://www.fda.gov/files/drugs/published/125526-Mepolizumab-Clinical-PREA.pdf
[Last accessed: September 2024].
- 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]
- Cottin V, et al. Respiratory manifestations of eosinophilic
granulomatosis with polyangiitis (Churg–Strauss). Eur Respir J.
2016;48:1429-1441.
- 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.
- 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].
- 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].
- 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].
- 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].
- AstraZeneca news release. Available at:
https://www.astrazeneca.com/media-centre/press-releases/2018/us-fda-grants-fasenra-orphan-drug-designation-for-eosinophilic-granulomatosis-with-polyangiitis-26112018.html.
[Last accessed: September 2024].
- IQVIA data on file. 2024.
- AstraZeneca Data on file. 2022. REF-244520.
- Baldini C, et al. Clinical Manifestations and Treatment of
Churg-Strauss Syndrome. Rheum Dis Clin N Am. 2010;36:527–543.
- Wechsler ME, et al. Mepolizumab or Placebo for Eosinophilic
Granulomatosis with Polyangiitis. N Engl J Med.
2017:376;1921-1932.
- 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.
- AstraZeneca data on file. 2024. REF-235794.
- 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].
- 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].
- Clinicaltrials.gov. A Phase 3 Study to Evaluate the Efficacy
and Safety of Benralizumab in Patients With Hypereosinophilic
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September 2024].
US-90967 Last Updated 9/17
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