Benralizumab: First Global Approval

Abstract

Kyowa Hakko Kirin, AstraZeneca and subsidiaries are developing benralizumab (Fasenra™)—a humanised anti-interleukin-5 receptor alpha chain (IL-5Rα) monoclonal antibody—as a treatment of severe eosinophilic asthma and chronic obstructive pulmonary disease (COPD). Eosinophilia is a characteristic of certain asthma and COPD phenotypes and depletion of eosinophils has demonstrated therapeutic benefit. Benralizumab was recently approved by the US FDA as add-on maintenance therapy for patients with severe asthma who have an eosinophilic phenotype. This article summarizes the milestones in the development of benralizumab leading to this first approval for the treatment of severe eosinophilic asthma.

This is a preview of subscription content, log in to check access.

References

  1. 1.

    Menzella F, Lusuardi M, Galeone C, et al. The clinical profile of benralizumab in the management of severe eosinophilic asthma. Ther Adv Respir Dis. 2016;10(6):534–48.

    CAS  Article  PubMed  Google Scholar 

  2. 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):2448–58.

    CAS  Article  PubMed  Google Scholar 

  3. 3.

    AstraZeneca. Fasenra (benralizumab) receives US FDA approval for severe eosinophilic asthma [media release]. https://www.astrazeneca.com/. 15 Nov 2017.

  4. 4.

    AstraZeneca. AstraZeneca receives EU approval of Fasenra for severe eosinophilic asthma [media release]. https://www.astrazeneca.com/. 10 Jan 2018.

  5. 5.

    AstraZeneca. Fasenra receives approval in Japan [media release]. https://www.astrazeneca.com/. 19 Jan 2018.

  6. 6.

    AstraZeneca. FASENRA (benralizumab) injection, for subcutaneous use: US prescribing information. 2017. http://www.fda.gov. Accessed 8 Jan 2018.

  7. 7.

    BioWa Inc. BioWa, Inc. licenses anti IL-5 receptor antibody from Kyowa Hakko Kogyo Co., Ltd [media release]. http://www.biowa.com. 22 Mar 2005.

  8. 8.

    MedImmune Inc., BioWa Inc. MedImmune strengthens inflammatory disease pipeline through collaboration with Biowa [media release]. http://www.medimmune.com. 19 Dec 2006.

  9. 9.

    AstraZeneca. AstraZeneca enters option agreement with Kyowa Hakko Kirin for commercialisation of benralizumab in Japan [media release]. http://www.astrazeneca.com. 16 Jul 2015.

  10. 10.

    Kyowa Hakko Kirin. Kyowa Hakko Kirin enters agreement with AstraZeneca for development and commercialisation of benralizumab in Asia [media release]. http://www.kyowa-kirin.coms. 24 Mar 2017.

  11. 11.

    Kolbeck R, Kozhich A, Koike M, et al. MEDI-563, a humanized anti-IL-5 receptor alpha mAb with enhanced antibody-dependent cell-mediated cytotoxicity function. J Allergy Clin Immunol. 2010;125(6):1344–1353.e2.

    CAS  Article  PubMed  Google Scholar 

  12. 12.

    Newbold P, Liu H, Pham TH, et al. Modulation of inflammation by benralizumab in eosinophilic airway disease [abstract no. PA4902]. Eur Respir J. 2016;48(Suppl 60).

  13. 13.

    European Medicines Agency. CHMP summary of positive opinion for Fasenra. 2017. http://www.ema.europa.eu/. Accessed 8 Feb 2018.

  14. 14.

    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.

    CAS  Article  PubMed  PubMed Central  Google Scholar 

  15. 15.

    Damera G, Brightling CE, Bleecker ER, et al. Pharmacodynamic effect of benralizumab on blood basophils and serum biomarkers in adults with chronic obstructive pulmonary disease and sputum eosinophilia [abstract no. P67]. Am J Respir Crit Care Med. 2015;191:A2711.

    Google Scholar 

  16. 16.

    Eck S, Castro M, Sinibaldi D, et al. Benralizumab effect on blood basophil counts in adults with uncontrolled asthma [abstract no. P297]. Eur Respir J. 2014;44(Suppl 58).

  17. 17.

    Busse WW, Katial R, Gossage D, et al. Safety profile, pharmacokinetics, and biologic activity of MEDI-563, an anti-IL-5 receptor alpha antibody, in a phase I study of subjects with mild asthma. J Allergy Clin Immunol. 2010;125(6):1237–1244.e2.

    CAS  Article  PubMed  Google Scholar 

  18. 18.

    Saito H, Yuji W, Kawai H, et al. Ascending single intravenous and subcutaneous dose studies of benralizumab in japanese healthy male volunteers: safety, tolerability, pharmacokinetics and pharmacodynamics [abstract no. P297]. Am J Respir Crit Care Med. 2015;191:A4270.

    Google Scholar 

  19. 19.

    Wang B, Yan L, Yao Z, et al. Population pharmacokinetics and pharmacodynamics of benralizumab in healthy volunteers and patients with asthma. CPT Pharmacomet Syst Pharmacol. 2017;6(4):249–57.

    CAS  Article  Google Scholar 

  20. 20.

    FitzGerald JM, Bleecker ER, Nair P, et al. Benralizumab, an anti-interleukin-5 receptor alpha 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):2128–41.

    CAS  Article  PubMed  Google Scholar 

  21. 21.

    Bleecker ER, FitzGerald JM, Chanez P, et al. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting beta2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016;388(10056):2115–27.

    CAS  Article  PubMed  Google Scholar 

  22. 22.

    Ferguson GT, Mansur AH, Jacobs JS, et al. Functionality, reliability, and performance of an accessorized pre-filled syringe with home-administered subcutaneous benralizumab for adult patients with severe asthma [abstract no. A3194]. Am J Respir Crit Care Med. 2017;195:1.

  23. 23.

    Ferguson GT, FitzGerald JM, Bleecker ER, et al. Benralizumab for patients with mild to moderate, persistent asthma (BISE): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Respir Med. 2017;5(7):568–76.

    CAS  Article  PubMed  Google Scholar 

  24. 24.

    Nowak RM, Parker JM, Silverman RA, et al. A randomized trial of benralizumab, an antiinterleukin 5 receptor alpha monoclonal antibody, after acute asthma. Am J Emerg Med. 2015;33(1):14–20.

    Article  PubMed  Google Scholar 

  25. 25.

    Castro M, Wenzel SE, Bleecker ER, et al. Benralizumab, an anti-interleukin 5 receptor alpha monoclonal antibody, versus placebo for uncontrolled eosinophilic asthma: a phase 2b randomised dose-ranging study. Lancet Respir Med. 2014;2(11):879–90.

    CAS  Article  PubMed  Google Scholar 

  26. 26.

    Park HS, Kim MK, Imai N, et al. A phase 2a study of benralizumab for patients with eosinophilic asthma in South Korea and Japan. Int Arch Allergy Immunol. 2016;169(3):135–45.

    CAS  Article  PubMed  Google Scholar 

  27. 27.

    Brightling CE, Bleecker ER, Panettieri RA Jr, et al. Benralizumab for chronic obstructive pulmonary disease and sputum eosinophilia: a randomised, double-blind, placebo-controlled, phase 2a study. Lancet Respir Med. 2014;2(11):891–901.

    CAS  Article  PubMed  PubMed Central  Google Scholar 

Download references

Author information

Affiliations

Authors

Corresponding author

Correspondence to A. Markham.

Ethics declarations

Funding

The preparation of this review was not supported by any external funding.

Conflict of interest

During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. A. Markham is a contracted employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.

Additional information about this Adis Drug Review can be found at http://www.medengine.com/Redeem/1CFCF0606E51C358.

Additional information

This profile has been extracted and modified from the AdisInsight database. AdisInsight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch and beyond.

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

Markham, A. Benralizumab: First Global Approval. Drugs 78, 505–511 (2018). https://doi.org/10.1007/s40265-018-0876-8

Download citation