MANDARA was a randomized, active-controlled, double-blind, multicenter, 52-week, Phase 3 noninferiority study with a ≥1 year open-label extension that evaluated the efficacy and safety of FASENRA compared to mepolizumab in the treatment of EGPA.1-3

Patients ACHIEVING remission
in the MANDARA study

mandara-study-arrow
mandara-study-arrow

PRIMARY ENDPOINT: Percent remission at Weeks 36 and 48 in patients taking FASENRA (N=70) and mepolizumab (N=70)1,2

In patients taking FASENRA (n=41)

59%

ACHIEVED REMISSION

vs

57%

taking mepolizumab (n=40)

FASENRA demonstrated noninferiority to mepolizumab for the primary endpoint of remission and the components of remission.1,2
remission-data-shapes
remission-data-shapes
REMISSION DEFINED AS:

No disease activity
(achieving BVAS=0)

+

daily OCS dose ≤4 mg

remission-data-shapes1
remission-data-shapes1

MANDARA OLE REMISSION DATA

The MANDARA Study included an OLE period to assess long-term safety and tolerability of benralizumab*3

KEY OLE LIMITATIONS: The OLE period only included FASENRA treatment arms. Treatment with mepolizumab was not assessed during the OLE period. The impact of remission and steroid reduction compared to FASENRA at 2 years remains unknown.3

Remission data—double-blind and OLE periods†3

remission-graphicremission-graphic

Results are descriptive only.

Help REDUCE disease activity in EGPA

reduce-disease-arrow
reduce-disease-arrow

No disease activity (BVAS=0) is one of the components of remission1

BVAS data measured at Weeks 36 and 48 in patients taking FASENRA (N=70) and mepolizumab (N=70)1,4

The MANDARA trial was a noninferiority trial and was not designed to assess whether FASENRA was superior to mepolizumab.1,2

In patients taking FASENRA (n=58),

83%

HAD NO DISEASE ACTIVITY (BVAS=0)

vs

84%

taking mepolizumab (n=59)

Results are descriptive only.

The MANDARA trial was a noninferiority trial and was not designed to assess whether FASENRA was superior to mepolizumab.1,2

OCS REDUCTION DATA IN PATIENTS WITH EGPA‡1,2,4

reduce-ocs-arrow
reduce-ocs-arrow

Percentage of patients eliminating OCS use

Secondary endpoint data from Weeks 48 through 52 in patients taking FASENRA (N=70) and mepolizumab (N=70)§

Graph Representing Percentage of Patients Eliminating OCS Use ≤4 mg/dayGraph Representing Percentage of Patients Eliminating OCS Use ≤4 mg/day

Percentage of patients reducing OCS dose to ≤4 mg/day

OCS reduction measured at Weeks 36 and 48 as a component of the primary endpoint in patients taking FASENRA (N=70) and mepolizumab (N=70)§

Graph Representing Percentage of Patients Reducing OCS DoseGraph Representing Percentage of Patients Reducing OCS Dose

An OCS dose of ≤4 mg/day is one of the components of remission1

Results are descriptive only.

The OCS dose was tapered at the discretion of the investigator.2 FASENRA demonstrated noninferiority to mepolizumab for the primary endpoint of remission and the components of remission.1,2 Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with FASENRA. Decrease corticosteroids gradually, if appropriate.

MANDARA OLE OCS REDUCTION DATA‡2,3

The MANDARA Study included an OLE period to assess long-term safety and tolerability of benralizumab.

KEY OLE LIMITATIONS: The OLE period only included FASENRA treatment arms. Treatment with mepolizumab was not assessed during the OLE period. The impact of remission and steroid reduction compared to FASENRA at 2 years remains unknown.3

Percentage of patients with 100% oral steroid reduction‡§3

Graph Representing Percentage of Patients With 100% Oral Steroid ReductionGraph Representing Percentage of Patients With 100% Oral Steroid Reduction

Results are descriptive only.

These results are not statistically significant as there was no prespecified multiple testing procedure. The OCS dose was tapered at the discretion of the investigator.2 Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with FASENRA. Decrease corticosteroids gradually, if appropriate.

*Out of those patients who completed the noninferiority, double-blind MANDARA study, 128 patients opted to enter the OLE and continued to receive (n=66) or started FASENRA (n=62) at Week 52.
Remission rates were analyzed for patients who were in both arms of the study.3

†Remission was defined as BVAS=0 and OCS ≤4 mg/day.2

‡The daily OCS dose was calculated regardless of the reason for administration. For patients who withdrew from the trial before Week 52, the daily OCS dose from the previous 28 days was used to derive the mean daily dose and percentage decrease from baseline during Weeks 48 through 52. Patients who discontinued treatment before Week 48 were considered to have not had a response in the analysis of the percentage reduction in OCS.2

§Percentages and percentage-point differences were estimated with the use of a marginal standardization method in a logistic-regression model, with treatment group, baseline dose of oral glucocorticoid, baseline BVAS, and region as covariates.2

BVAS, Birmingham Vasculitis Activity Score; OCS, oral corticosteroid.

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%):

  • Asthma: headache, pharyngitis
  • EGPA: headache
  • HES: headache, hypersensitivity reactions, influenza-like illness

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.

Pediatrics: The safety and efficacy of FASENRA in asthma patients less than 6 and in EGPA patients less than 18 years of age has not been established.

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)
  • the treatment of adult and adolescent patients aged 12 years and older with hypereosinophilic syndrome (HES) without an identifiable non-hematologic secondary cause

Please read full Prescribing Information, including Patient Information.

Please read full Prescribing Information, including Patient Information.

You may report side effects related to AstraZeneca products .

IMPORTANT SAFETY INFORMATION

 +

References

Reference

1. FASENRA® (benralizumab) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2026. 2. Wechsler ME, Nair P, Terrier B, et al; MANDARA Study Group. Benralizumab versus mepolizumab for eosinophilic granulomatosis with polyangiitis. N Engl J Med. 2024;390(10):911-921.

1. Fagni F, Bello F, Emmi G. Eosinophilic granulomatosis with polyangiitis: dissecting the pathophysiology. Front Med (Lausanne). 2021;8:627776. 2. Khoury P, Grayson PC, Klion AD. Eosinophils in vasculitis: characteristics and roles in pathogenesis. Nat Rev Rheumatol. 2014;10(8):474-483. 3. Emmi G, Bettiol A, Gelain E, et al. Evidence-based guideline for the diagnosis and management of eosinophilic granulomatosis with polyangiitis. Nat Rev Rheumatol. 2023;19(6):378-393. 4. Matucci A, Vivarelli E, Perlato M, et al. EGPA phenotyping: not only ANCA, but also eosinophils. Biomedicines. 2023;11(3):776. 5. Furuta S, Iwamoto T, Nakajima H. Update on eosinophilic granulomatosis with polyangiitis. Allergol Int. 2019;68(4):430-436. 6. Chakraborty RK, Rout P. Eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome). In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025. Updated September 19, 2024. Accessed July 8, 2025. https://www.ncbi.nlm.nih.gov/books/NBK537099/ 7. Baldini C, Talarico R, Della Rossa A, Bombardieri S. Clinical manifestations and treatment of Churg-Strauss syndrome. Rheum Dis Clin North Am. 2010;36(3):527-543.

1. FASENRA® (benralizumab) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; September 2024.

1. FASENRA® (benralizumab) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; September 2024. 2. Wechsler ME, Nair P, Terrier B, et al; MANDARA Study
Group. Benralizumab versus mepolizumab for eosinophilic granulomatosis with polyangiitis. N Engl J Med. 2024;390(10):911-921. 3. Merkel PA, Nair PK, Khalidi N, et al; MANDARA Study Group. Two-year efficacy and safety of anti-interleukin-5/receptor therapy for eosinophilic granulomatosis with polyangiitis. Ann Rheum Dis. 2025;84(11):1888-1899. doi:10.1016/j.ard.2025.06.2131 4. Merkel PA, Nair PK, Khalidi N, et al; MANDARA Study Group. Two-year efficacy and safety of anti-interleukin-5/receptor therapy for eosinophilic granulomatosis with polyangiitis. Ann Rheum Dis. 2025;(suppl). doi:10.1016/j.ard.2025.06.2131

1. Grayson PC, Ponte C, Suppiah R, et al. 2022 American College of Rheumatology/European Alliance of Associations for Rheumatology classification criteria for eosinophilic granulomatosis with polyangiitis. Ann Rheum Dis. 2022;81(3):309-314. 2. Jennette JC, Falk RJ, Bacon PA, et al. 2012 revised International Chapel Hill Consensus Conference nomenclature of vasculitides. Arthritis Rheum. 2013;65(1):1-11. 3. Furuta S, Iwamoto T, Nakajima H. Update on eosinophilic granulomatosis with polyangiitis. Allergol Int. 2019;68(4):430-436. 4. Chakraborty RK, Rout P. Eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome). In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025. Updated September 19, 2024. Accessed July 8, 2025. https://www.ncbi.nlm.nih.gov/books/NBK537099/ 5. Trivioli G, Terrier B, Vaglio A. Eosinophilic granulomatosis with polyangiitis: understanding the disease and its management. Rheumatology (Oxford). 2020;59(suppl 3):iii84-iii94.

1. FASENRA® (benralizumab) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; September 2024. 2. Wechsler ME, Nair P, Terrier B, et al; MANDARA Study Group. Benralizumab versus mepolizumab for eosinophilic granulomatosis with polyangiitis. N Engl J Med. 2024;390(10):911-921. 3. Wechsler ME, Nair P, Terrier B, et al; MANDARA Study Group. Benralizumab versus mepolizumab for eosinophilic granulomatosis with polyangiitis. N Engl J Med. 2024;390(10)(suppl):1-46. 4.
Merkel PA, Nair PK, Khalidi N, et al; MANDARA Study Group. Two-year efficacy and safety of anti-interleukin-5/receptor therapy for eosinophilic granulomatosis with polyangiitis. Ann Rheum Dis. 2025;84(11):1888-1899. doi:10.1016/j.ard.2025.06.2131

1. FASENRA® (benralizumab) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; September 2024. 2. Wechsler ME, Nair P, Terrier B, et al; MANDARA Study Group. Benralizumab versus mepolizumab for eosinophilic granulomatosis with polyangiitis. N Engl J Med. 2024;390(10):911-921. 3. Merkel PA, Nair PK, Khalidi N, et al; MANDARA Study Group. Two-year efficacy and safety of anti-interleukin-5/receptor therapy for eosinophilic granulomatosis with polyangiitis. Ann Rheum Dis. 2025;84(11):1888-1899. doi:10.1016/j.ard.2025.06.2131 4. Wechsler ME, Nair P, Terrier B, et al; MANDARA Study Group. Benralizumab versus mepolizumab for eosinophilic granulomatosis with polyangiitis. N Engl J Med. 2024;390(10)(suppl):1-46.

1. FASENRA® (benralizumab) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; September 2024. 2. Wechsler ME, Nair P, Terrier B, et al; MANDARA Study Group. Benralizumab versus mepolizumab for eosinophilic granulomatosis with polyangiitis. N Engl J Med. 2024;390(10):911-921. 3. Wechsler ME, Nair P, Terrier B, et al; MANDARA Study Group. Benralizumab versus mepolizumab for eosinophilic granulomatosis with polyangiitis. N Engl J Med. 2024;390(10)(suppl):1-46.

1. FASENRA® (benralizumab) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; September 2024. 2. Wechsler ME, Nair P, Terrier B, et al; MANDARA Study Group. Benralizumab versus mepolizumab for eosinophilic granulomatosis with polyangiitis. N Engl J Med. 2024;390(10):911-921. 3. Data on File, US-103275, AZPLP. 4. Merkel PA, Nair PK, Khalidi N, et al; MANDARA Study Group. Two-year efficacy and safety of anti-interleukin-5/receptor therapy for eosinophilic granulomatosis with polyangiitis. Ann Rheum Dis. 2025;84(11):1888-1899. doi:10.1016/j.ard.2025.06.2131

1. FASENRA® (benralizumab) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; September 2024. 2. Wechsler ME, Nair P, Terrier B, et al; MANDARA Study Group. Benralizumab versus mepolizumab for eosinophilic granulomatosis with polyangiitis. N Engl J Med. 2024;390(10):911-921. 3. Nucala® (mepolizumab) [package insert]. Philadelphia, PA: GlaxoSmithKline LLC; August 2025.