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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LONG-TERM DATA

MOVE TO REDUCE EXACERBATIONS

Demonstrated exacerbation reduction in pivotal studies.

Data from the MELTEMI open-label extension trial are displayed below.

MELTEMI Open-Label Extension Study: PERCENTAGE OF PATIENTS WITH ZERO EXACERBATIONS OVER 5 YEARS1

Observed in MELTEMI, an open-label extension study. Results are descriptive only.

Graph Representing the Percentage of Patients with Zero Exacerbations Over 5 Years
Graph Representing the Percentage of Patients with Zero Exacerbations Over 5 Years
  • Over 5 years, at least 75% of patients had ZERO EXACERBATIONS each year

Results are descriptive only.

In MELTEMI, patients could continue in the study until FASENRA was commercially available in their local market or for 130 weeks in countries in which a marketing application was not submitted.1 As FASENRA became approved in various markets, patient numbers declined. Mean treatment duration for FASENRA Q8W was 3.7 years.

Study limitations: Patients who did not experience benefits with their asthma treatment may have been more likely to discontinue the study vs those who did experience benefits and, similarly, patients who experienced certain SAEs in predecessor studies were not eligible to enter MELTEMI, both of which could contribute to selection bias.1

In predecessor studies, patients received placebo or FASENRA 30 mg SC, either Q4W or Q8W (first 3 doses Q4W); in BORA, patients receiving placebo were randomized to FASENRA Q4W or Q8W and continued on the same treatment in MELTEMI until FASENRA was commercially available in their local market. In MELTEMI, patients received either FASENRA 30 mg SC Q4W or FASENRA 30 mg SC Q8W. Patients enrolled in MELTEMI were aged 18 years or older, had a diagnosis of severe asthma, and were being treated with ICS/LABA therapy ± OCS and/or other asthma controllers. Mean treatment duration for FASENRA Q8W was 3.7 years. Efficacy analysis includes patients with bEOS ≥300 cells/μL receiving high-dose ICS at baseline. Of the patients receiving FASENRA Q8W, 59% had zero exacerbations across the extension study period (n=110; over 304 total follow-up years). The primary endpoint was safety and tolerability measured by rates of AEs and SAEs.

Study Limitations

Patients who did not experience benefits with their asthma treatment may have been more likely to discontinue the study vs those who did experience benefits and, similarly, patients who experienced certain SAEs in predecessor studies were not eligible to enter MELTEMI, both of which could contribute to selection bias.

Inclusion Criteria

  • Enrolled in the double-blind BORA extension study
  • At baseline, treated with ICS/LABA therapy ± OCS and/or other asthma controllers
  • Adults (aged 18-75 years) with severe, uncontrolled asthma
  • At baseline, treated with ICS/LABA therapy ± OCS and/or other asthma controllers
  • Adults (aged 18-75 years) with severe, uncontrolled asthma
  • Completed one of the three Phase 3, randomized, double-blind, placebo-controlled predecessor studies
Flowchart Summarizing the MELTEMI Trial for Exacerbation Reductions Flowchart Summarizing the MELTEMI Trial for Exacerbation Reductions

*FASENRA 30 mg Q4W or 30 mg Q8W and placebo.1

†FASENRA 30 mg Q4W or 30 mg Q8W.1

‡Eligible patients transitioned into BORA at the EOT visit of the predecessor study.1

§Includes patients who discontinued treatment in MELTEMI but attended all study visits.1

||447 patients enrolled in MELTEMI; 1 patient did not receive treatment with study drug and was not included in the full analysis set.1

AE, adverse event; bEOS, blood eosinophil; EOT, end of treatment; ICS, inhaled corticosteroid; LABA, long-acting beta-agonist; OCS, oral corticosteroid; Q4W, every 4 weeks; Q8W, every 8 weeks; SAE, serious adverse event; SC, subcutaneous.

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Q8W, every 8 weeks; SAE, serious adverse event.

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.