Blueprint
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 November
2018
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
US FDA grants
Fasenra ODD for EGPA
26 November 2018 07:00 GMT
US FDA grants Fasenra
Orphan Drug Designation
for Eosinophilic
Granulomatosis with Polyangiitis
AstraZeneca
today announced that the US Food and Drug Administration (FDA) has
granted Orphan Drug Designation (ODD) for Fasenra (benralizumab) for the
treatment of Eosinophilic Granulomatosis with Polyangiitis
(EGPA).
EGPA is
a rare autoimmune disease that can cause damage to multiple organs
and tissues.1 The FDA grants ODD
status to medicines intended for the treatment, diagnosis or
prevention of rare diseases or disorders that affect fewer than
200,000 people in the US.
Sean
Bohen, Executive Vice President, Global Medicines Development and
Chief Medical Officer, said: "EGPA is a rare, but debilitating
inflammatory disease and patients with the disease typically have
very high levels of eosinophils. Our clinical trials for
Fasenra in severe,
eosinophilic asthma show it depletes eosinophils and we are
exploring the potential of this medicine to address unmet medical
needs in other eosinophil-driven diseases."
EGPA is
characterised by inflammation of blood vessels and the presence of
elevated levels of eosinophils, a type of white blood
cell.1
Fasenra induces rapid and
near-complete depletion of eosinophils in the blood and has proven
efficacy in severe, eosinophilic asthma, which suggests it may
benefit patients with EGPA.2,3
Fasenra is AstraZeneca's first respiratory biologic and
is currently approved as an add-on maintenance treatment for
severe, eosinophilic asthma in the US, EU, Japan and several other
jurisdictions.
About EGPA
EGPA,
formerly known as Churg-Strauss Syndrome, is a rare, chronic
autoimmune disease that is caused by inflammation of small to
medium-sized blood vessels.4 EGPA can result in
damage to multiple organs, including lungs, skin, heart,
gastrointestinal tract and nerves.1 The most common
symptoms include extreme fatigue, weight loss, muscle and joint
pain, rashes, nerve pain, sinus and nasal symptoms, and shortness
of breath.1,4,5 Without
treatment, the disease may be fatal.1
Elevated
levels of eosinophils play a central role in EGPA disease
pathophysiology. All patients with EGPA have very high levels of
eosinophils at some point in their disease, both in peripheral
blood and in affected tissues or organs.1,4 People with EGPA
usually have asthma that may have developed as an adult, and often
have sinus and nasal symptoms.4
There
are few effective medicines for EGPA. Patients are often treated
with chronic high-dose oral corticosteroids (OCS) and can
experience recurrent relapses when attempting to taper off
OCS.4,6
About Fasenra
Fasenra (benralizumab) is a monoclonal antibody that binds
directly to IL-5 receptor a 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 several other jurisdictions, with
further regulatory reviews ongoing. Where approved, Fasenra is available as a fixed-dose
subcutaneous injection via a prefilled syringe administered once
every 4 weeks for the first 3 doses, and then once every 8 weeks
thereafter. Fasenra is also
being studied in severe nasal polyposis. Phase III trials for
Fasenra in EGPA have not
commenced.
Fasenra was developed by AstraZeneca with MedImmune, the
company's global biologics research and development arm, and is
in-licensed from BioWa, Inc., a wholly-owned subsidiary of Kyowa
Hakko Kirin Co., Ltd., Japan.
About AstraZeneca in Respiratory Disease
Respiratory
disease is one of AstraZeneca's main therapy areas, and
the Company has a growing portfolio of medicines that reached more
than 18 million patients in 2017. 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-5rɑ), now approved for severe, eosinophilic asthma and
in development for severe nasal polyposis, 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
is focused on addressing underlying disease drivers focusing on the
lung epithelium, lung immunity and lung regeneration.
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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Adrian Kemp
Company Secretary
AstraZeneca PLC
References
1. American Partnership for Eosinophilic
Disorders. Eosinophilic Granulomatosis with Polyangiitis (EGPA).
Accessed 20 November 2018. https://apfed.org/about-ead/eosinophilic-granulomatosis-with-polyangiitis/.
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.
4.
Baldini C, Talarico R, Della Rossa A, Bombardieri S. Clinical
Manifestations and Treatment of Churg-Strauss Syndrome.
Rheum Dis Clin N Am. 2010;
36: 527-543.
5. Vasculitis Foundation. Eosinophilic
Granulomatosis with Polyangiitis Fact Sheet. Available via https://docs.google.com/file/d/0B6Ey09QSlQ65ZTYzSXYyVTlfVHM/edit.
6. Wechsler M. Akuthota P, Jayne D,
Khoury P. Mepolizumab or Placebo for Eosinophilic Granulomatosis
with Polyangiitis. N Engl J
Med. 2017 May 18; 376(20): 1921-1932.
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:
26 November
2018
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By: /s/
Adrian Kemp
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Name:
Adrian Kemp
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Title:
Company Secretary
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