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 July 2019
Commission
File Number: 001-11960
AstraZeneca PLC
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Fasenra
receives positive EU CHMP opinion for self
1 July 2019 07:00 BST
Fasenra receives positive EU CHMP opinion for
self-administration
and the new Fasenra pen, a pre-filled, single-use
auto-injector
AstraZeneca today announced that the European Medicines Agency's
Committee for Medicinal Products for Human Use (CHMP) has issued a
positive opinion to add a self-administration option
for Fasenra(benralizumab) and a new delivery method as a
pre-filled, single-use auto-injector (the Fasenra pen) to the medicine's product information
in the European Union.
The CHMP opinion can be implemented without the need for a
European Commission decision due to the nature of the Type-II label
variation.
The positive opinion for self-administration and
the Fasenra pen is supported by the Phase III GREGALE
and GRECO trials, and the Phase I AMES trial, respectively. The
safety and tolerability of Fasenra in these trials were consistent with the
known profile of the medicine.
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&D, said: "Fasenra is the only respiratory biologic medicine
that can be administered every eight weeks after the initial
loading-dose period, and this positive opinion means we are closer
to offering Fasenra in a way that is even more convenient for
many patients. We hope self-administration and
the Fasenra pen will play important roles in helping
physicians make treatment with biologic medicines accessible to
more people with severe eosinophilic asthma."
AstraZeneca anticipates a regulatory decision by the US Food and
Drug Administration (FDA) on self-administration and the new
pre-filled, single-use auto-injector device in the second half of
2019. Fasenra is currently approved as an add-on
maintenance treatment for severe eosinophilic asthma in the US, EU,
Japan and other countries.
About self-administration and
the Fasenra pen
Fasenra will be available
as both a fixed 30mg subcutaneous injection via a pre-filled,
single-use syringe or the Fasenra pen, both with a thin 29-gauge needle,
administered once every four weeks for the first three doses, and
once every eight weeks thereafter.
The new Fasenra pen enables patients and caregivers to
administer the medicine via a simple two-step process. The
device includes a viewing window and audible clicks at the start
and end of the injection to guide patients with successful
administration.
About the GREGALE, GRECO and AMES trials
GREGALE is a Phase III, multicentre, open-label, 28-week,
functionality, reliability and performance trial of
30mg Fasenra administered subcutaneously (SC) every four
weeks in clinic and at home through week 16 with a pre-filled
syringe in 120 adult patients with severe, uncontrolled
asthma.1 The
majority of patients and caregivers successfully
administered Fasenra at home using a pre-filled syringe at week
12 (98%) and week 16 (99%). The majority of returned pre-filled
syringes (99%) used to administer at home were considered
functional at week 12 and week 16.
GRECO is a Phase III multicentre, open-label, 28-week trial designed to assess
patient- or caregiver-reported functionality, performance and
reliability of a pre-filled auto-injector device with a fixed 30mg
dose of Fasenra administered SC every four weeks in clinic
and in an at-home setting in 120 adults with severe,
uncontrolled asthma.2 The
majority (97%) of at-home administrations by patients or caregivers
were successful at week 12 and week 16 and nearly all (96%)
returned pre-filled auto-injector devices used to
administer Fasenra at home were evaluated as functional at week
12 and week 16. The majority (97%) of at-home administrations by
patients or caregivers were successful at week 12 and week 16.
Nearly all (96%) returned auto-injector devices used to
administer Fasenra at home were evaluated as functional at week
12 and week 16.
AMES is a multicentre, randomised, open-label, parallel group Phase
I trial in healthy subjects to compare the pharmacokinetic (PK)
exposure following single 30mg SC administration
of Fasenra by using pre-filled syringe or pre-filled
auto-injector devices.3 Fasenra PK
exposure was comparable following SC administration via a
pre-filled syringe or a pre-filled auto-injector. Eosinophils were
rapidly depleted in patients from both device
groups.
The safety profile in all three trials was similar to previous
trials, with no new or unexpected safety findings. The most common
adverse events observed in each trial were: GRECO - viral upper
respiratory tract infection, asthma, upper respiratory tract
infection, headache; GREGALE - nasopharyngitis, upper respiratory
tract infection, headache, sinusitis; AMES - nasopharyngitis,
headache, oropharyngeal pain.1,2,3
About Fasenra
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 eosinophils via apoptosis (programmed
cell death).19,20
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 countries, with further regulatory reviews
ongoing. Fasenra is also in development for severe nasal
polyposis, other eosinophilic diseases, and chronic obstructive
pulmonary disease. The FDA granted Orphan Drug Designation
for Fasenra for the treatment of eosinophilic
granulomatosis with polyangiitis (EGPA) in November 2018 and
hypereosinophilic syndrome (HES) in February
2019.
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 5R 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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Adrian Kemp
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AstraZeneca PLC
References
1. Study to Assess Functionality,
Reliability, and Performance of a Pre-filled Syringe With
Benralizumab Administered at Home (GREGALE).
ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02417961.
Accessed 17 April 2019.
2. Study to Assess Functionality,
Reliability, and Performance of a Single-Use Auto-Injector With
Benralizumab Administered at Home (GRECO).
ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02918071.
Accessed 17 April 2019.
3. Pharmacokinetic Comparability of
Benralizumab Using Accessorized Pre-Filled Syringe or Autoinjector
in Healthy Volunteers. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02968914.
Accessed 17 April 2019.
4.
Chanez P, Humbert M. European respiratory review: Asthma: still a
promising future? European
Respiratory Review. 2014, 23 (134) 405-407.
5. The
Global Asthma Network. The Global Asthma Report 2018. [Online].
Available at:
http://www.globalasthmanetwork.org/publications/Global_Asthma_Report_2018.pdf.
Last accessed: September 2018.
6.
Chung KF, Wenzel SE, Brozek JL, et al. International ERS/ATS
guidelines on definition, evaluation and treatment of severe
asthma. Eur Respir
J 2014; 43: 343-73.
7.
Wenzel, Severe Asthma in Adults. Am J Respir Crit Care Med. 2005;
172 VOL 172; 149-160, 2005.
8.
Peters SP, Ferguson G, Deniz Y, et al. Uncontrolled asthma: a
review of the prevalence, disease burden and options for
treatment. Respir
Med. 2006: 100(7):1139-51.
9.
Zhang, JY and Wenzel, SE. Tissue and BAL based biomarkers in
asthma. Immunol Allergy Clin
North Am. 2007; 27: 623-632 (vi.).
10. Fernandes
AG, Souza-Machado C, Coelho RC et al. Risk factors for death in
patients with severe asthma. J Bras Pneumol. 2014; 40(4):
364-372.
11. Schleich
F, Demarche S, Louis R. Biomarkers in the Management of Difficult
Asthma. Current Topics in
Medicinal Chemistry. 2016;16(14):1561-1573.
12. Aslan F,
Altun E, Paksoy S, Turan G. Could Eosinophilia predict clinical
severity in nasal polyps? Multidisciplinary Respiratory Medicine.
2017;12(1).
13. Leckie
MJ, Brinke AT, Khan J, et al. Effects of an interleukin-5 blocking
monoclonal antibody on eosinophils, airway hyper-responsiveness,
and the late asthmatic response. The Lancet.
2000;356(9248):2144-2148.
14. Sweeney
J, et al. Thorax 2016;71:339-346.
15. Hyland ME
et al. Quality of Life
Research. 2016; 24:631-639.
16. Hyland
ME, Whalley B, Jones RC, et al. A qualitative study of the impact
of severe asthma and its treatment showing that treatment burden is
neglected in existing asthma assessment scales. Quality of Life Research. 2015: 24 (3)
631-619.
17. Zeiger RS
et al. J Allergy Clin Immunol
Pract. 2017;5:1050-1060.
18. World
Allergy Organization (WAO). The management of severe asthma:
economic analysis of the cost of treatments for severe asthma.
Available from:
http://www.worldallergy.org/educational_programs/world_allergy_forum/anaheim2005/blaiss.php.
Last accessed April 2018.
19. 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.
20. 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:
01 July
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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