TIDMAZN
RNS Number : 3730K
AstraZeneca PLC
28 August 2019
28 August 2019 07:05 BST
Fasenra granted US Orphan Drug Designation
for eosinophilic oesophagitis
AstraZeneca today announced that the US Food and Drug
Administration (FDA) has granted Orphan Drug Designation (ODD) to
Fasenra (benralizumab) for the treatment of eosinophilic
oesophagitis (EoE).
EoE is a rare, chronic, inflammatory disease that occurs when
eosinophils, a type of white blood cell, accumulate in the
oesophagus causing injury and inflammation.(1) 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.
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&D, said: "Eosinophilic oesophagitis is an allergic
inflammatory disease that can affect children and adults, and
typically patients experience a range of debilitating symptoms
including severe pain and difficulty swallowing food. Currently
there are no FDA-approved treatments for eosinophilic oesophagitis.
Because Fasenra depletes eosinophils in blood and tissue, it could
become a potential new medicine to treat patients with this rare
disease."
Fasenra is AstraZeneca's first respiratory biologic medicine and
is currently approved as an add-on maintenance treatment for
severe, eosinophilic asthma in the US, EU, Japan and other
countries. In November 2018, the FDA granted ODD for Fasenra for
the treatment of eosinophilic granulomatosis with polyangiitis
(EGPA), and also granted ODD for the treatment of hypereosinophilic
syndrome (HES) in February 2019.
About EoE
EoE is a rare, chronic, inflammatory disease of the oesophagus
characterised by the accumulation of eosinophils, a type of white
blood cell that are a normal part of the immune system, in the
oesophageal lining tissue. The disease results in injury, fibrosis
and dysfunction that if not effectively treated can make eating
difficult or uncomfortable, potentially leading to chronic pain,
difficulty swallowing, poor growth, malnutrition and weight
loss.(1)
The most common symptoms of EoE include reflux that does not
respond to medication, difficulty swallowing, food becoming stuck
in the oesophagus, nausea and vomiting, abdominal or chest pain,
poor appetite and difficulty sleeping.(1)
Patients are often treated with corticosteroids to manage
inflammation. Currently there are no FDA-approved treatments for
EoE.(1)
About Fasenra
Fasenra (benralizumab) is a monoclonal antibody that binds
directly to the IL-5 receptor alpha on eosinophils and attracts
natural killer cells to induce rapid and near-complete depletion of
eosinophils via apoptosis (programmed cell death).(2,3)
Fasenra is AstraZeneca's first respiratory biologic, now
approved as an add-on maintenance treatment in severe eosinophilic
asthma in the US, EU, Japan and other countries, with further
regulatory reviews ongoing. In June 2019, the European Medicines
Agency's Committee for Medicinal Products for Human Use (CHMP)
issued a positive opinion for Fasenra self-administration and the
Fasenra pen, a new auto-injector delivery device. Fasenra is in
development for severe nasal polyposis, eosinophilic oesophagitis,
eosinophilic granulomatosis with polyangiitis, hypereosinophilic
syndrome and chronic obstructive pulmonary disease.
Fasenra was developed by AstraZeneca and is in-licensed from
BioWa, Inc., a wholly-owned subsidiary of Kyowa Hakko Kirin Co.,
Ltd., Japan.
About AstraZeneca in respiratory diseases
Respiratory is one of AstraZeneca's three therapy areas, and our
medicines reached more than 18 million patients as maintenance
therapy in 2018. AstraZeneca's aim is to transform asthma and COPD
treatment through inhaled combinations at the core of care,
biologics for the unmet needs of specific patient populations, and
scientific advancements in disease modification.
The Company is building on a 40-year heritage in respiratory
disease and AstraZeneca's capability in inhalation technology spans
pressurised metered-dose inhalers and dry powder inhalers, as well
as the Aerosphere delivery technology. The company also has a
growing portfolio of respiratory biologics including Fasenra
(anti-eosinophil, anti-IL 5 alpha), and tezepelumab (anti-TSLP)
which has been granted Breakthrough Therapy Designation by the US
Food and Drug Administration in patients with severe asthma and is
in Phase III trials. AstraZeneca's research aims at addressing
underlying disease drivers by focusing on the lung epithelium, lung
immunity, lung regeneration and neuronal functions.
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company
that focuses on the discovery, development and commercialisation of
prescription medicines, primarily for the treatment of diseases in
three therapy areas - Oncology, Cardiovascular, Renal &
Metabolism, and Respiratory. AstraZeneca operates in over 100
countries and its innovative medicines are used by millions of
patients worldwide. For more information, please visit
astrazeneca.com and follow us on Twitter @AstraZeneca.
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References
1. EoE. Available at: https://apfed.org/about-ead/egids/eoe. Last accessed: 1 July 2019.
2. Kolbeck R, Kozhich A, Koike M, 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
Jun;125(6):1344-1353.e2.
3. Pham TH, Damera G, Newbold P, Ranade K. Reductions in
eosinophil biomarkers by benralizumab in patients with asthma.
Respir Med. 2016; 111:21-29.
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