FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of August
2019
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F X Form 40-F __
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(1):
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(7): ______
Indicate
by check mark whether the registrant by furnishing the information
contained in this Form is also thereby furnishing the information
to the Commission pursuant to Rule 12g3-2(b) under the Securities
Exchange Act of 1934.
Yes __
No X
If
“Yes” is marked, indicate below the file number
assigned to the Registrant in connection with Rule 12g3-2(b):
82-_____________
AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Fasenra
granted US Orphan Drug Designation for eosinophilic
oesophagitis
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.
|
Media
Relations
|
|
|
|
Gonzalo
Viña
|
|
+44 203
749 5916
|
|
Rob
Skelding
|
Oncology
|
+44 203
749 5821
|
|
Rebecca
Einhorn
|
Oncology
|
+1 301
518 4122
|
|
Matt
Kent
|
BioPharmaceuticals
|
+44 203
749 5906
|
|
Jennifer
Hursit
|
Other
|
+44
203 749 5762
|
|
Christina Malmberg
Hägerstrand
|
Sweden
|
+46 8 552 53 106
|
|
Michele
Meixell
|
US
|
+1 302
885 2677
|
|
|
|
|
|
Investor
Relations
|
|
|
|
Thomas
Kudsk Larsen
|
|
+44 203
749 5712
|
|
Henry
Wheeler
|
Oncology
|
+44 203
749 5797
|
|
Christer
Gruvris
|
BioPharmaceuticals
(CV, metabolism)
|
+44 203
749 5711
|
|
Nick
Stone
|
BioPharmaceuticals
(respiratory, renal)
|
+44 203
749 5716
|
|
Josie
Afolabi
|
Other
medicines
|
+44 203
749 5631
|
|
Craig
Marks
|
Finance,
fixed income
|
+44
7881 615 764
|
|
Jennifer
Kretzmann
|
Corporate
access, retail investors
|
+44 203
749 5824
|
|
US
toll-free
|
|
+1 866
381 72 77
|
|
|
|
|
Adrian Kemp
Company Secretary
AstraZeneca PLC
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.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
Date:
28 August
2019
|
|
By: /s/
Adrian Kemp
|
|
|
Name:
Adrian Kemp
|
|
|
Title:
Company Secretary
|