FASENRA approved for treatment of children aged 6 to 11 with severe asthma

Additional indication for pediatric patients with severe eosinophilic asthma

AstraZeneca's FASENRA® (benralizumab) is now approved by the US Food and Drug Administration (FDA) for add-on maintenance treatment for patients with severe asthma aged 6 to 11 with an eosinophilic phenotype.¹ FASENRA was first approved in 2017 as an add-on maintenance for the treatment of severe eosinophilic asthma (SEA) in patients aged 12 and older.¹

This additional indication for FASENRA was supported by evidence from TATE, an open-label, multinational, non-randomized, parallel assignment Phase III trial, as well as adequate and well-controlled trials in adult and adolescent populations.² In the TATE study, FASENRA met the primary endpoints, demonstrating pharmacokinetics (PK) and pharmacodynamics (PD) in children aged 6 to 11 years old with SEA were consistent with those seen in prior trials. The safety and tolerability of FASENRA in the trial was also consistent with the known profile of the medicine.² The recommended dose for FASENRA is 30 mg for patients 6 years and older who weigh 35 kg or more. For patients aged 6 to 11 who weigh less than 35 kg, a new 10 mg dose will be available.¹ FASENRA is administered by subcutaneous injection every 4 weeks for the first 3 doses, and then every 8 weeks.

Lynda Mitchell, MA, CAE, CEO, of the Allergy & Asthma Network, said: "We welcome additional treatment options for children living with severe asthma, a condition that remains complicated to manage, further helping to address the unmet need in this patient population and reducing the burden of disease for the broader asthma community."

Asthma is the most common chronic childhood disease and can cause serious symptoms such as coughing, wheezing and difficulty breathing.³ Children with severe asthma and their families face a significant burden, including impaired school performance, substantially higher healthcare resource use and a poorer quality of life.⁴ Severe asthma is a debilitating type of asthma that can be complicated and challenging to treat.⁴

Liz Bodin, Vice President, US Respiratory & Immunology, AstraZeneca said: "We're proud that FASENRA has helped more than 100,000 patients in the US to date. Expanding options for children whose quality of life has been drastically impacted by severe eosinophilic asthma with the help of FASENRA is an exciting step in our mission to revolutionize asthma care."

FASENRA is currently approved as an add-on maintenance treatment for patients aged 6 and older with SEA in the US.¹

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Known hypersensitivity to benralizumab or excipients.

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions

Hypersensitivity reactions (e.g., 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 (i.e., 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%) include headache and pharyngitis.

Injection site reactions (e.g., 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.

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.

INDICATION

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 treatment of other eosinophilic conditions
• FASENRA is not indicated for the relief of acute bronchospasm or status asthmaticus

Please read full Prescribing Information, including Patient Information and Instructions for Use.

You may report side effects related to AstraZeneca products.

Notes

TATE Phase III Trial

TATE was an open-label, Phase III trial evaluating the safety of FASENRA in children aged 6 to 11 years with severe eosinophilic asthma. The trial evaluated the PK, PD and safety of FASENRA administered subcutaneously in 28 children in the US and Japan aged 6 to 11 years, in addition to 2 patients aged 12 to 14 years in Japan with severe eosinophilic asthma over 48 weeks.²

FASENRA met the primary endpoints in the trial, demonstrating PK, PD, and safety in children aged 6 to 11 years old with SEA were consistent with those seen in prior trials.

FASENRA

FASENRA is a monoclonal antibody that binds directly to IL-5 receptor alpha on eosinophils and attracts natural killer cells to induce rapid and near-complete depletion of blood and tissue eosinophils in most patients via apoptosis (programmed cell death).^5,6

FASENRA (benralizumab) is currently approved in more than 80 countries, including the US, EU, and Japan, and is approved for self-administration in the US, EU and other countries.^7-10 FASENRA has been prescribed to over 100,000 patients in the US.¹¹

FASENRA is in development for other diseases including chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps and hypereosinophilic syndrome.^12-14

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 BioPharmaceuticals, is one of AstraZeneca's main disease areas and is a key growth driver for the Company.

AstraZeneca is an established leader in respiratory care with a 50-year heritage. The Company aims to transform the treatment of asthma and COPD by focusing on earlier biology-led treatment, eliminating preventable asthma attacks, and removing COPD as a top-three leading cause of death. The Company's early respiratory research is focused on emerging science involving immune mechanisms, lung damage and abnormal cell-repair processes in disease and neuronal dysfunction.

With common pathways and underlying disease drivers across respiratory and immunology, AstraZeneca is following the science from chronic lung diseases to immunology-driven disease areas. The Company's growing presence in immunology is focused on five mid- to late-stage franchises with multi-disease potential, in areas including rheumatology (including systemic lupus erythematosus), dermatology, gastroenterology, and systemic eosinophilic-driven diseases. AstraZeneca's ambition in Respiratory & Immunology is to achieve disease modification and durable remission for millions of patients worldwide.

AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit www.astrazeneca-us.com and follow us on social media @AstraZeneca.

References

1. FASENRA US prescribing information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761070Orig1s020correctedlbl.pdf. [Last accessed April 2024].
2. Wedner HJ, Fujisawa T, Guilbert TW, et al on behalf of the TATE Investigators. Benralizumab in children with severe eosinophilic asthma: pharmacokinetics and long-term safety (TATE study). Pediatri Allergy Immunol 2024;35:e14092.
3. World Health Organization. Asthma. Available at: https://www.who.int/news-room/fact-sheets/detail/asthma. [Last accessed April 2024].
4. Castagnoli R, Marseglia A, Brambilla I, Marseglia GL, Licari A. Severe uncontrolled asthma in children: practical approach on diagnosis and management. Minerva Pediatr. 2020;72(3):196-205.
5. Kolbeck R, et al. MEDI-563, a humanized anti-IL-5 receptor a mAb with enhanced antibody-dependent cell-mediated cytotoxicity function. J Allergy Clin Immunol. 2010;125:1344-1353.e2.
6. Pham TH, et al. Reductions in eosinophil biomarkers by benralizumab in patients with asthma. Respir Med. 2016;111:21-29.
7. 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: April 2024].
8. 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: April 2024].
9. 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: April 2024].
10. 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: April 2024].
11. AstraZeneca plc. FY and Q4 2023 Results. Conference call and webcast for investors and analysts. Available at: https://www.astrazeneca.com/media-centre/press-releases/2024/full-year-and-q4-2023-results.html. [Last accessed April 2024].
12. 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: April 2024].
13. 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: April 2024].
14. 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: April 2024].

 US-83378 Last Updated 4/8

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