Orphan Drug Designations in eosinophilic gastritis and eosinophilic gastroenteritis mark Fasenra’s fourth and fifth Orphan Drug Designation in eosinophilic diseases
US Food and Drug Administration also granted Fast Track Designation for Fasenra in eosinophilic gastritis with or without eosinophilic gastroenteritis
Fasenra (benralizumab) has been granted Orphan Drug Designations (ODDs) for the treatment of eosinophilic gastritis (EG) and eosinophilic gastroenteritis (EGE) as well as a Fast Track Designation (FTD) for the treatment of EG with or without EGE in the US by the Food and Drug Administration (FDA).
EG and EGE are rare, chronic relapsing conditions that may co-exist or be independent.1-3 These diseases have symptoms that are primarily related to eosinophilic tissue inflammation, which can cause tissue injury and remodelling of the gastrointestinal tract.1-5
The FDA grants ODD status to medicines and potential new medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US.6 FTD status is granted for medicines in the US to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need so that important new drugs get to the patient earlier.7
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: “In patients with eosinophilic gastritis and eosinophilic gastroenteritis, an excess of eosinophils contributes to a variety of potentially debilitating gastrointestinal symptoms, including abdominal pain, vomiting, and diarrhoea. Unfortunately, there are currently no FDA-approved treatments for these diseases. Based on Fasenra’s eosinophil-depleting mechanism of action, we’re hopeful it can help address these unmet needs and improve patient outcomes.”
EG and EGE may be driven by eosinophilic immune dysfunction (EID), a process characterised by the dysregulation of biological mechanisms involved with eosinophil recruitment and activation that enable eosinophils to infiltrate patients’ tissue to cause and worsen disease in a range of tissues and organ systems throughout the body.8,9
A Phase III clinical trial (HUDSON) is initiating to evaluate the efficacy and safety of Fasenra in patients with EG and/or EGE.10
Fasenra is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in the US, EU, Japan and other countries11 and is approved for self-administration in the US12 and EU.13 The FDA granted ODD for Fasenra for eosinophilic granulomatosis with polyangiitis (EGPA) (November 2018),14 hypereosinophilic syndrome (HES) (February 2019)15 and eosinophilic esophagitis (EoE) (August 2019).16
EG and EGE
EG and EGE are rare, chronic relapsing conditions that may co-exist or be independent.1-3 These diseases have symptoms that are primarily related to eosinophilic tissue inflammation, which can cause tissue injury and remodelling of the gastrointestinal tract.1-5 These diseases can result in a variety of debilitating gastrointestinal symptoms such as abdominal pain, nausea, vomiting, satiety (feeling overfull), loss of appetite, and diarrhoea.1-4 Patients’ vigilant monitoring of a likely restricted diet, with potential to affect adequate and balanced nutrition, has a severe impact on patients’ daily lives.17,18
There are no approved treatments.3 Disease management includes strict dietary changes with more severe patients receiving locally acting or oral corticosteroids.2,4,5
EID is characterised as the dysregulation of biological mechanisms involved with eosinophil recruitment and activation that may be driving a diverse range of inflammatory diseases, including EG and EGE. Other examples include severe eosinophilic asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), EoE, EGPA, HES, bullous pemphigoid and atopic dermatitis. These disorders have complex pathogenic mechanisms, including but not limited to eosinophil-mediated organ damage and dysfunction.
Fasenra (benralizumab) 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).19,20
Fasenra is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in the US, EU, Japan and other countries,11 and is approved for self-administration in the US,12 EU13 and other countries.
Fasenra is in development for other eosinophilic diseases including atopic dermatitis, bullous pemphigoid, chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria, eosinophilic esophagitis, eosinophilic gastritis/eosinophilic gastroenteritis, eosinophilic granulomatosis with polyangiitis, hypereosinophilic syndrome and non-cystic fibrosis bronchiectasis.21-30
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 (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 operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.
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Veeva ID: Z4-39583
Date of Preparation: November 2021