FASENRA is indicated for the add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma, and with an eosinophilic phenotype. FASENRA is not for the relief of acute bronchospasm or status asthmaticus.

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Exacerbation Reduction DATA

POWERFUL: EXACERBATION REDUCTIONS FOR PATIENTS WITH EOSINOPHILS ≥300 CELLS/μL1,2

EXACERBATION REDUCTION DATA

POWERFUL: EXACERBATION REDUCTIONs FOR PATIENTS WITH EOSINOPHILS ≥300 CELLS/μL1,2

PRIMARY ENDPOINT OF PIVOTAL TRIALS

AER of FASENRA + SOC vs placebo + SOC in patients with baseline blood eosinophil levels of ≥300 cells/μL who were taking high-dose ICS/
LABA*

Exacerbation Reductions (%)

Chart Representing Percentage of Exacerbation ReductionsChart Representing Percentage of Exacerbation Reductions

Results from CALIMA (56 weeks):
FASENRA (n=239) resulted in an AER of 0.73
—28% lower than the AER of 1.01 observed with placebo (n=248; P=0.019)1,3

ADDITIONAL POST HOC SUBGROUP ANALYSIS DATA FROM SIROCCO AND CALIMA

Annual exacerbation rates by IgE and atopic status with FASENRA

Post Hoc Pooled SIROCCO/CALIMA: AAER by IgE and Atopic Status

Patients receiving high-dose ICS/LABA with baseline bEOS ≥300 cells/μL‡§4

Graph Representing Annual Exacerbation Rates by IgE and Atopic Status With FASENRA
Graph Representing Annual Exacerbation Rates by IgE and Atopic Status With FASENRA

FASENRA was studied across predefined subgroups. This study was not designed to assess efficacy in individual subgroups but rather to visualize consistency across subgroups.

Predefined subgroups were analyzed for AER based on IgE level and atopic status.

Results are descriptive only.

A total of 1204 (SIROCCO) and 1306 (CALIMA) patients aged 12-75 years old with severe asthma uncontrolled on high-dose ICS (SIROCCO) and medium- to high-dose ICS (CALIMA) plus LABA with or without additional controllers were included. Patients had a history of ≥2 exacerbations requiring systemic corticosteroids or temporary increase in usual dosing in the previous year. Patients were stratified by geography, age, and blood eosinophil counts (≥300 cells/μL and <300 cells/μL). The primary endpoint was annual exacerbation rate ratio vs placebo in patients with blood eosinophil counts of ≥300 cells/μL on high-dose ICS/LABA. Exacerbations were defined as a worsening of asthma that led to use of systemic corticosteroids for ≥3 days, temporary increase in a stable OCS background dose for ≥3 days, emergency/
urgent care visit because of asthma that needed systemic corticosteroids, or inpatient hospital stay of ≥24 hours because of asthma. Key secondary endpoints were prebronchodilator FEV1 and total asthma symptom score at Week 48 (SIROCCO) and Week 56 (CALIMA) in the same population.

SIROCCO

Flowchart Summarizing the SIROCCO Study Design and Results for Exacerbation Reductions

Flowchart Summarizing the SIROCCO Study Design and Results for Exacerbation Reductions

CALIMA

Flowchart Summarizing the CALIMA Study Design and Results for Exacerbation Reductions

Flowchart Summarizing the CALIMA Study Design and Results for Exacerbation Reductions

*Patients in the Q8W FASENRA arm received a placebo injection at the 4-week interval between FASENRA injections.2,3

†Patients randomized were stratified for blood eosinophil counts of ≥300 cells/μL and <300 cells/μL.2,3

EOT, end of treatment; FEV1, forced expiratory volume in 1 second; ICS, inhaled corticosteroid; LABA, long-acting beta-agonist; OCS, oral corticosteroid; Q4W, every 4 weeks; Q8W, every 8 weeks; SC, subcutaneous.

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*SOC was defined as high-dose ICS (SIROCCO) and medium- to high-dose ICS (CALIMA) + LABA with or without other controllers, including systemic steroids.2,3

†AER was defined as the total number of exacerbations multiplied by 365.25, divided by the total duration of follow-up (days) within the treatment group.2,3

‡Based on a pooled prespecified analysis from the ITT population of SIROCCO/CALIMA treatment cohorts in patients with severe eosinophilic asthma on high-dose ICS/
LABA. Atopy was defined as having a positive Phadiatop test reaction. A post hoc analysis was performed on patients based on high or low serum IgE concentrations (≥150 kU/L and <150 kU/L, respectively), chosen post hoc, and atopic or nonatopic status.4

§AAER was calculated using a negative binomial model, with adjustment for study code, treatment, region, OCS use at time of randomization, and prior exacerbations. Corresponding follow-up time of patients was used as an offset variable to adjust for different exposure times during which the events occurred. If appropriate, estimates were reweighted to account for the 2:1 stratification for baseline blood eosinophil counts (≥300 cells/μL and <300 cells/μL). All comparator results of benralizumab vs placebo use nominal P values and no formal statistical significance can be inferred.4

||With atopy: AAER estimate 1.10 for placebo and 0.66 for benralizumab; without atopy: AAER estimate 1.15 for placebo and 0.62 for benralizumab. For high IgE: AAER estimate 1.09 for placebo and 0.63 for benralizumab; for low IgE: AAER estimate 1.21 for placebo and 0.68 for benralizumab.4

AAER, annual asthma exacerbation rate; AER, annual exacerbation rate; CI, confidence interval; ICS, inhaled corticosteroid; lgE, immunoglobulin E; ITT, intent to treat; LABA, long-acting beta-agonist; OCS, oral corticosteroid; Q4W, every 4 weeks; Q8W, every 8 weeks; RR, rate ratio; SOC, standard of care.

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

A pregnancy exposure registry monitors pregnancy outcomes in women exposed to FASENRA during pregnancy. To enroll call 1-877-311-8972 or visit www.mothertobaby.org/fasenra.

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)
  • 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

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References

Reference

1. Data on File, US-107034, AZPLP. 2. FASENRA® (benralizumab) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2026. 3. Bleecker ER, FitzGerald JM, Chanez P, et al; SIROCCO study investigators. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting β2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016;388(10056):2115-2127. 4. FitzGerald JM, Bleecker ER, Nair P, et al; CALIMA study investigators. Benralizumab, an anti-interleukin-5 receptor α monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2016;388(10056):2128-2141.

 

1. Korn S, Bourdin A, Chupp G, et al. Integrated safety and efficacy among patients receiving benralizumab for up to 5 years. J Allergy Clin Immunol Pract. 2021;9(12):4381-4392.e4.

1. FASENRA® (benralizumab) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; September 2024. 2. Laviolette M, Gossage DL, Gauvreau G, et al. Effects of benralizumab on airway eosinophils in asthmatic patients with sputum eosinophilia. J Allergy Clin Immunol. 2013;132(5):1086-1096.e5.

1. Data on File, REF-51332, AZPLP. 2. Bleecker ER, FitzGerald JM, Chanez P, et al; SIROCCO study investigators. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting ß2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016;388(10056):2115-2127. 3. Skolnik NS, Carnahan SP. Primary care of asthma: new options for severe eosinophilic asthma. Curr Med Res Opin. 2019;35(7):1309-1318. 4. Tran TN, Zeiger RS, Peters SP, et al. Overlap of atopic, eosinophilic, and TH2-high asthma phenotypes in a general population with current asthma. Ann Allergy Asthma Immunol. 2016;116(1):37-42.

1. FASENRA® (benralizumab) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; September 2024. 2. Bleecker ER, FitzGerald JM, Chanez P, et al; SIROCCO study investigators. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting ß2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016;388(10056):2115-2127. 3. FitzGerald JM, Bleecker ER, Nair P, et al; CALIMA study investigators. Benralizumab, an anti-interleukin-5 receptor α monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2016;388(10056):2128-2141. 4. Chipps BE, Newbold P, Hirsch I, Trudo F, Goldman M. Benralizumab efficacy by atopy status and serum immunoglobulin E for patients with severe, uncontrolled asthma. Ann Allergy Asthma Immunol. 2018;120(5):504-511.e4.

1. FASENRA® (benralizumab) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; September 2024. 2. Nair P, Wenzel S, Rabe KF, et al. Oral glucocorticoid–sparing effect of benralizumab in severe asthma. N Engl J Med. 2017;376(25):2448-2458. 3. Menzies-Gow A, Corren J, Bel EH, et al. Corticosteroid tapering with benralizumab treatment for eosinophilic asthma: PONENTE trial. ERJ Open Res. 2019;5(3):00009-2019. 4. Menzies-Gow A, Gurnell M, Heaney LG, et al. Oral corticosteroid elimination via a personalised reduction algorithm in adults with severe, eosinophilic asthma treated with benralizumab (PONENTE): a multicentre, open-label, single-arm study. Lancet Respir Med. 2022;10(1):47-58. 5. Menzies-Gow A, Gurnell M, Heaney LG, et al. Adrenal function recovery after durable oral corticosteroid sparing with benralizumab in the PONENTE study. Eur Respir J. 2022;60(6):2103226.

1. FASENRA® (benralizumab) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; September 2024. 2. Bleecker ER, FitzGerald JM, Chanez P, et al; SIROCCO study investigators. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting ß2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016;388(10056):2115-2127. 3. FitzGerald JM, Bleecker ER, Nair P, et al; CALIMA study investigators. Benralizumab, an anti-interleukin-5 receptor α monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2016;388(10056):2128-2141. 4. Busse WW, Bleecker ER, FitzGerald JM, et al; BORA study investigators. Long-term safety and efficacy of benralizumab in patients with severe, uncontrolled asthma: 1-year results from the BORA phase 3 extension trial. Lancet Respir Med. 2019;7(1):46-59. 5. FitzGerald JM, Bleecker ER, Bourdin A, et al. Two-year integrated efficacy and safety analysis of benralizumab in severe asthma. J Asthma Allergy. 2019;12:401-413. 6. Data on File, REF-19697, AZPLP. 7. Data on File, REF-59636, AZPLP. 8. Chipps BE, Hirsch I, Trudo F, et al. Benralizumab efficacy for patients with fixed airflow obstruction and severe, uncontrolled eosinophilic asthma. Ann Allergy Asthma Immunol. 2020;124(1):79-86. 9. Kaminska M, Foley S, Maghni K, et al. Airway remodeling in subjects with severe asthma with or without chronic persistent airflow obstruction. J Allergy Clin Immunol. 2009;124(1):45-51.e1-4. 10. Rutting S, Thamrin C, Cross TJ, King GG, Tonga KO. Fixed airflow obstruction in asthma: a problem of the whole lung not of just the airways. Front Physiol. 2022;13:898208.

1. Skolnik NS, Carnahan SP. Primary care of asthma: new options for severe eosinophilic asthma. Curr Med Res Opin. 2019;35(7):1309-1318. 2. Global Initiative for Asthma. 2025 GINA Report, Global Strategy for Asthma Management and Prevention. Accessed May 27, 2025. https://ginasthma.org/reports 3. Bleecker ER, FitzGerald JM, Chanez P, et al; SIROCCO study investigators. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting β2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016;388(10056):2115-2127. 4. Tran TN, Zeiger RS, Peters SP, et al. Overlap of atopic, eosinophilic, and TH2-high asthma phenotypes in a general population with current asthma. Ann Allergy Asthma Immunol. 2016;116(1):37-42.

1. Data on File, US-94507, AZPLP.

1. FASENRA® (benralizumab) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; April2024 .

1. Data on File, REF-211303, AZPLP. 2. Jackson DJ, Pelaia G, Emmanuel B, et al. Benralizumab in severe eosinophilic asthma by previous biologic use and key clinical subgroups: real-world XALOC-1 programme. Eur Respir J. 2024;64(1):2301521. 3. Carstens D, Maselli DJ, Mu F, et al. Real-world effectiveness study of benralizumab for severe eosinophilic asthma: ZEPHYR 2. J Allergy Clin Immunol Pract. 2023;11(7):2150-2161.e4. 4. FASENRA® (benralizumab) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; September 2024. 5. Bleecker ER, FitzGerald JM, Chanez P, et al; SIROCCO study investigators. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting ß2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016;388(10056):2115-2127. 6. Penz E, Rothe T, Dupont L, et al. Early and sustained asthma control and remission in real-world patients with severe eosinophilic asthma treated with benralizumab: XALOC-2. Clin Exp Allergy. Published online October 29, 2025. doi:10.1111/cea.70162 7. Penz E, Rothe T, Dupont L, et al. Early and sustained asthma control and remission in real-world patients with severe eosinophilic asthma treated with benralizumab: XALOC-2. Supplemental materials. Clin Exp Allergy. Published online October 29, 2025. doi:10.1111/cea.70162

1. FASENRA® (benralizumab) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; September 2024. 2. Bleecker ER, FitzGerald JM, Chanez P, et al; SIROCCO study investigators. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting ß2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016;388(10056):2115-2127. 3. FitzGerald JM, Bleecker ER, Nair P, et al; CALIMA study investigators. Benralizumab, an anti-interleukin-5 receptor α monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2016;388(10056):2128-2141. 4. Nair P, Wenzel S, Rabe KF, et al. Oral glucocorticoid–sparing effect of benralizumab in severe asthma. N Engl J Med. 2017;376(25):2448-2458. 5. Busse WW, Bleecker ER, FitzGerald JM, et al; BORA study investigators. Long-term safety and efficacy of benralizumab in patients with severe, uncontrolled asthma: 1-year results from the BORA phase 3 extension trial. Lancet Respir Med. 2019;7(1):46 -59. 6. Korn S, Bourdin A, Chupp G, et al. Integrated safety and efficacy among patients receiving benralizumab for up to 5 years. J Allergy Clin Immunol Pract. 2021;9(12):4381-4392.e4. 7. Menzies-Gow A, Gurnell M, Heaney LG, et al. Oral corticosteroid elimination via a personalised reduction algorithm in adults with severe, eosinophilic asthma treated with benralizumab (PONENTE): a multicentre, open-label, single-arm study. Lancet Respir Med. 2022;10(1):47-58. 8. Menzies-Gow A, Corren J, Bel EH, et al. Corticosteroid tapering with benralizumab treatment for eosinophilic asthma: PONENTE trial. ERJ Open Res. 2019;5(3):00009-2019. 9. Menzies-Gow A, Gurnell M, Heaney LG, et al. Adrenal function recovery after durable oral corticosteroid sparing with benralizumab in the PONENTE study. Eur Respir J. 2022;60(6):2103226. 10. Data on File, REF -211303, AZPLP. 11. Jackson DJ, Pelaia G, Emmanuel B, et al. Benralizumab in severe eosinophilic asthma by previous biologic use and key clinical subgroups: real-world XALOC-1 programme. Eur Respir J. 2024;64(1):2301521. 12. Carstens D, Maselli DJ, Mu F, et al. Real-world effectiveness study of benralizumab for severe eosinophilic asthma: ZEPHYR 2. J Allergy Clin Immunol Pract. 2023;11(7):2150-2161.e4. 13. Penz E, Rothe T, Dupont L, et al. Early and sustained asthma control and remission in real-world patients with severe eosinophilic asthma treated with benralizumab: XALOC-2. Clin Exp Allergy. Published online October 29, 2025. doi:10.1111/cea.70162 14. Penz E, Rothe T, Dupont L, et al. Early and sustained asthma control and remission in real-world patients with severe eosinophilic asthma treated with benralizumab: XALOC-2. Supplemental materials. Clin Exp Allergy. Published online October 29, 2025. doi:10.1111/cea.70162

1. FASENRA® (benralizumab) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; September 2024. 2. Korn S, Bourdin A, Chupp G, et al. Integrated safety and efficacy among patients receiving benralizumab for up to 5 years. J Allergy Clin Immunol Pract. 2021;9(12):4381-4392.e4. 3. Data on File, US-103275, AZPLP. 4. ClinicalTrials.gov [Internet]. National Library of Medicine (US). Identifier NCT00783289 ClinicalTrials.gov website. Accessed July 10, 2025. https://clinicaltrials.gov/ct2/show/NCT00783289

1. FASENRA® (benralizumab) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; September 2024. 2. Ferguson GT, Cole J, Aurivillius M, Roussel P, Barker P, Martin UJ; GRECO study investigators. Single-use autoinjector functionality and reliability for at-home administration of benralizumab for patients with severe asthma: GRECO trial results. J Asthma Allergy. 2019;12:363-373.

1. FASENRA® (benralizumab) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; April 2024. 2. Bleecker ER, FitzGerald JM, Chanez P, et al; SIROCCO study investigators. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting ß2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016;388(10056):2115-2127. 3. FitzGerald JM, Bleecker ER, Nair P, et al; CALIMA study investigators. Benralizumab, an anti-interleukin-5 receptor α monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2016;388(10056):2128-2141.

1. Formulary data are provided by Fingertip Formulary® and are current as of October 6, 2025.