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 February
2019
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
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United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
US FDA grants Fasenra Orphan Drug Designation
6 February 2019 07:00 GMT
US FDA grants Fasenra Orphan Drug Designation
for hypereosinophilic syndrome
The US Food and Drug Administration (FDA) has granted Orphan Drug
Designation (ODD) to Fasenra(benralizumab) for the treatment of
hypereosinophilic syndrome (HES).
HES is a group of rare, potentially fatal disorders characterised
by high numbers of eosinophils in blood and tissues, which can
cause progressive damage to any organ in the
body.1,2 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.
A Phase II clinical trial of Fasenra for the treatment of HES has been conducted
by the United States National Institutes of Health in collaboration
with AstraZeneca, with results expected to be published later in
2019. In the trial, Fasenra depleted blood eosinophils at week 12
compared with placebo, the primary endpoint of the trial, with
evidence of eosinophil clearance in affected tissue at week
24.3
Mene Pangalos, Executive Vice President, R&D
BioPharmaceuticals, said: "In patients with hypereosinophilic
syndrome, high levels of eosinophils contribute to a range of
debilitating symptoms and can even lead to life-threatening organ
damage. Based on results from the Phase II trial, we
believe Fasenra has the potential to address critical unmet
medical needs in patients living with hypereosinophilic
syndrome."
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 countries. In November 2018, the
FDA granted
ODD for Fasenra for the treatment of eosinophilic
granulomatosis with polyangiitis (EGPA).
About hypereosinophilic syndrome (HES)
HES is a group of rare disorders in which high numbers of
eosinophils are found in the blood and tissue which can cause
progressive organ damage over time, and if left untreated, can be
fatal.1,2 HES
most commonly impacts the skin, heart, lungs, gastrointestinal
tract and central nervous system.2
The symptoms of HES may include cough, fever, fatigue, asthma,
difficulty breathing, wheezing, recurrent upper respiratory tract
infections, abdominal pain, vomiting, diarrhoea, skin rashes,
arthritis, muscle aches and joint pain.2
The goal of HES treatment is to reduce eosinophils in the blood and
tissues, prevent organ damage and slow disease
progression.2,4 HES
treatment typically includes glucocorticoids, immunomodulatory
therapies and cytotoxic therapies.1
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).5,6
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 HES have not yet
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 is one of AstraZeneca's main 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-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. Hypereosinophilic
Syndromes. Accessed 2 February 2019.
apfed.org/about-ead/hypereosinophilic-syndrome/.
2. American
Partnership for Eosinophilic Disorders. APFED Hypereosinophilic
Syndromes Brochure. December 2017. Accessed 2 February 2019.
apfed.org/wp-content/uploads/2017/12/APFED_HES_bro_final.pdf
3.
Kuang FL, Legrand F, Makiya MA, Panch S, Ware J, Wetzler L, Brown
T, Magee T, Kumar S, Alao H, Maric I, Khoury P, Klion AD.
Benralizumab is a well-tolerated and effective treatment for
PDGFRA-negative hypereosinophilic syndrome (Oral Poster 1).
Presented at the 10th Biennial Symposium of the International
Eosinophil Society (IES), 19-23
July 2017, Gothenburg, Sweden
4.
Klion AD. How I treat hypereosinophilic syndromes. Blood.
2015;126(9):1069-77.
5.
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.
6. 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:
06 February
2019
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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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