Approval based on MIRACLE Phase III trial demonstrating a significant and clinically meaningful reduction in asthma exacerbations and improvement in asthma symptom control.

AstraZeneca’s Fasenra (benralizumab) has been approved in China by the country’s National Medical Products Association (NMPA) for the maintenance treatment of patients 12 years of age and older with severe eosinophilic asthma (SEA).¹

The approval is based on results from the MIRACLE Phase III trial, which was conducted in China, South Korea and the Philippines.² In the trial, Fasenra achieved a statistically significant and clinically meaningful 74% reduction (0.49 in the Fasenra group compared to 1.88 in the placebo group, rate ratio 0.26, p<0.0001) in the annualised asthma exacerbation rate (AAER) when added to standard of care in patients with SEA.² Fasenra met all primary and key secondary endpoints in the trial, demonstrating improvements in lung function and asthma symptom control.²

It is estimated that approximately 3 million people in China have SEA.^3-6 Despite the significant prevalence in China, treatment options are limited, and severe asthma is often misdiagnosed and undertreated.³ The burden of SEA for patients is significant with patients experiencing frequent exacerbations, significant limitations on lung function and a reduced quality of life.^7-10 Patients with severe asthma are at an increased risk of mortality and compared to patients with persistent asthma, have twice the risk of asthma-related hospitalisations.^11-13 There is also a significant socio-economic burden, with these patients accounting for approximately 50% of asthma-related costs.¹⁴

Dr. Nanshan Zhong, Academician of the Chinese Academy of Engineering, and International Coordinating Investigator of the trial said: “Many patients in China with severe eosinophilic asthma have uncontrolled disease and experience frequent exacerbations, symptom worsening and reduced lung function despite the use of inhaled therapies. There are several ongoing studies to address these unmet needs in China. The recent MIRACLE trial showed that benralizumab, which has a unique mechanism of action, can help patients achieve early and sustained control of their asthma symptoms. There’s now potential for many more patients in China to benefit from treatment.”

Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca said: “Today’s approval is an important step forward in the treatment of severe asthma in China, which affects millions of patients. Those living with severe asthma will soon have access to Fasenra, which rapidly targets eosinophils, resulting in a significant reduction of asthma exacerbations and clinically meaningful symptom relief for patients.”

The safety and tolerability profile for benralizumab in the MIRACLE trial was consistent with the known safety profile of the medicine.²

Fasenra is currently approved as an add-on maintenance treatment for SEA in more than 80 countries, including the US, Japan, EU and now China.^15-18It is also approved in children and adolescents ages 6 and above in the US and Japan.

Notes

Severe Asthma

Asthma is a major chronic respiratory disease that affects an estimated 300 million people worldwide.² Up to 10% of people with asthma have severe asthma that is uncontrolled.² Eosinophilic inflammation drives the eosinophilic phenotype of asthma, which is seen in more than 80% of patients with severe asthma.² Patients may be uncontrolled despite high dosages of standard of care asthma controller medicines, experiencing frequent exacerbations and significant limitations on lung function and health-related quality of life as a result.^7-10,19

MIRACLE

MIRACLE was a randomised, double-blind, parallel group, placebo-controlled Phase III trial in China, South Korea, and Philippines evaluating the efficacy and safety of Fasenra in 695 patients aged 12 to 75 years of age with a history of uncontrolled asthma who received medium or high-dose inhaled corticosteroid plus long-acting β₂-agonist (ICS-LABA) with or without oral corticosteroids and additional asthma controllers.²

The primary endpoint was a reduction in the AAER over 48 weeks in patients with severe eosinophilic asthma and baseline blood eosinophil count (bEOS) ≥300/μL on 30mg Fasenra subcutaneous eight-week dosing compared to placebo. All patients were randomised to either placebo or Fasenra (1:1 ratio). Fasenra achieved a statistically significant and clinically meaningful 74% reduction (0.49 in the Fasenra group compared to 1.88 in the placebo group, rate ratio 0.26, p<0.0001).²

Patients were stratified by country/region, age group (adult or adolescent), and peripheral blood eosinophil count at time of visit 1 (<300 or ≥300 cells/μL). Key secondary efficacy endpoints were change from baseline at Week 48 in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1) and total asthma symptom score (TASS) in patients with baseline bEOS ≥300/μL. Other secondary efficacy endpoints included change from baseline in morning and evening peak expiratory flow (PEF), Asthma Control Questionnaire 6 (ACQ-6), St. George’s Respiratory Questionnaire (SGRQ), AAER associated with an emergency room (ER)/urgent care (UC) visit or hospitalisation, time to first asthma exacerbation and proportion of patients with ≥1 asthma exacerbation, and blood eosinophil levels.²

Fasenra

Fasenra (benralizumab) is currently approved in more than 80 countries, including the US, EU, Japan and now China.^15-18 Fasenra has been prescribed to over 130,000 patients globally.²⁰

Fasenra is in development for other diseases, including chronic obstructive pulmonary disease (COPD), chronic rhinosinuitis with nasal polyps (CRSwNP), eosinophilic granulomatosis with polyangiitis (EGPA), and hypereosinophilic syndrome.^21-24

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 AstraZeneca BioPharmaceuticals, is a key disease area and growth driver to the Company.

AstraZeneca is an established leader in respiratory care with a 50-year heritage and a growing portfolio of medicines in immune-mediated diseases. The Company is committed to addressing the vast unmet needs of these chronic, often debilitating, diseases with a pipeline and portfolio of inhaled medicines, biologics and new modalities aimed at previously unreachable biologic targets. Our ambition is to deliver life-changing medicines that help eliminate COPD as a leading cause of death, eliminate asthma attacks and achieve clinical remission in immune-mediated diseases.

AstraZeneca

AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on social media @AstraZeneca

Contacts

For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here.

References

1. National Medical Products Administration approval, August 2024
2. Lai K, et al. Benralizumab efficacy and safety in severe asthma: a randomized trial in Asia. Respir Med. 2024
3. Huang K, et al. China Pulmonary Health (CPH) Study Group. Prevalence, risk factors, and management of asthma in China: a national cross-sectional study. Lancet. 2019;394(10196):407-418
4. Wang WY, et al. A survey on clinical characteristics and risk factors of severe asthma in China. Zhonghua Yi Xue Za Zhi. 2020;100(14):1106-1111
5. Su N, et al. A cross-section study of severe asthma in eight provinces of China. Zhonghua Nei Ke Za Zhi. 2016;55(12):917-921
6. Zhang Q, et al. C-BIOPRED consortium. Severe eosinophilic asthma in Chinese C-BIOPRED asthma cohort. Clin Transl Med. 2022;12(2):e710
7. Menzies-Gow A, et al. A Charter to Improve Patient Care in Severe Asthma. Adv Ther. 2018 Oct;35(10):1485-1496
8. Wenzel S. Severe asthma in adults. Am J Respir Crit Care Med. 2005;172:149-60
9. Peters SP, et al. Uncontrolled asthma: a review of the prevalence, disease burden and options for treatment. Respir Med. 2006;100(7): 1139-51
10. Wang E, et al. Characterization of Severe Asthma Worldwide. Data from the International Severe Asthma Registry. Chest. 2020;157(4): 790-804
11. Chastek B, et al. Economic Burden of Illness Among Patients with Severe Asthma in a Managed Care Setting. J Manag Care Spec Pharm. 2016;22: 848–861
12. Hartert TV, et al. Risk factors for recurrent asthma hospital visits and death among a population of indigent older adults with asthma. Ann Allergy Asthma Immunol. 2002;89: 467–73
13. Price D, et al. Asthma control and management in 8,000 European patients: the REcognise Asthma and LInk to Symptoms and Experience (REALISE) survey. NPJ Prim Care Respir Med. 2014; 24: 14009
14. World Allergy Organization (WAO). The management of severe asthma: economic analysis of the cost of treatments for severe asthma. Available at: https://www.worldallergy.org/educational_programs/world_allergy_forum/anaheim2005/blaiss.php.  [Last accessed: August 2024]
15. 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: August 2024].
16. 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: August 2024].
17. 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: August 2024].
18. 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: August 2024].
19. Chung KF, Wenzel SE, Brozek JL, et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J 2014; 43: 343–73.
20. AstraZeneca Data on file. 2024. REF-235794.
21. 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: August 2024]
22. 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: August 2024]
23. Wechsler ME, et al. Benralizumab versus Mepolizumab for Eosinophilic Granulomatosis with Polyangiitis. N Engl J Med. 2024 Available at: https://www.nejm.org/stoken/default+domain/REPRINTS_36237/full?redirectUri=/doi/full/10.1056/NEJMoa2311155.[Last accessed: August 2024]
24. Clinicaltrials.gov. A Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab in Patients With Hypereosinophilic Syndrome (HES) (NATRON). Available from: https://clinicaltrials.gov/ct2/show/NCT04191304. [Last accessed: August 2024]