FASENRA approved for treatment of children aged 6 to 11 with severe asthma - Seite 3

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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.