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 2020
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.
Breztri Aerosphere
approved in the US for the maintenance treatment of
COPD
24 July 2020 07:00 BST
Breztri
Aerosphere approved in the
US for the maintenance treatment of COPD
Approval based on Phase III ETHOS trial which showed a
statistically significant reduction in the rate of exacerbations
compared with dual-combination therapies
AstraZeneca's Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate)
has been approved in the US for the maintenance treatment of
patients with chronic obstructive pulmonary disease
(COPD).
The approval by the US Food and Drug Administration (FDA) was based
on positive results from the Phase III ETHOS trial in
which Breztri
Aerosphere, a
triple-combination therapy, showed a statistically significant
reduction in the rate of moderate or severe exacerbations compared
with dual-combination therapies Bevespi
Aerosphere (glycopyrrolate/formoterol fumarate) and
PT009 (budesonide/formoterol fumarate).1 The
approval was also supported by efficacy and safety data from the
Phase III KRONOS trial.2
Dr. Fernando J. Martinez, Chief of Division of Pulmonary and
Critical Care Medicine at Weill Cornell Medicine and New
York-Presbyterian Weill Cornell Medical Center, New York, US and
Investigator in the ETHOS trial, said: "Preventing exacerbations is
central to the management of chronic obstructive pulmonary disease.
Even a single exacerbation can have a negative impact on a
patient's lung function and quality of life, and it can increase
the risk of death. Breztri Aerosphere has demonstrated significant benefits in
reducing exacerbations in patients suffering from
COPD."
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&D, said: "Breztri
Aerosphere has
demonstrated a strong clinical profile compared with
dual-combination therapies and offers a meaningful new treatment
option for patients. Chronic obstructive pulmonary disease is a
debilitating progressive condition and the fourth leading cause of
death in the US. We look forward to discussing all-cause mortality
data from the Breztri
Aerosphere ETHOS trial
with health authorities."
Results from the Phase III ETHOS trial were published
in The
New England Journal of Medicine1 in
June 2020 and results from the Phase III KRONOS trial were
published in The Lancet
Respiratory Medicine in September 2018.2 In
both trials, the safety and tolerability
of Breztri
Aerosphere were consistent
with the profiles of the dual comparators.1,2
Breztri Aerosphere is not
indicated for the relief of acute bronchospasm or for the treatment
of asthma in the US or other countries. Breztri
Aerosphere is approved in
Japan and China for patients with COPD and under regulatory review
in the EU.
Financial considerations
Under the terms of the past agreement to acquire Pearl Therapeutics
Inc., AstraZeneca will make a $150m milestone payment upon US
regulatory approval of Breztri
Aerosphere for COPD. This
is the final development and regulatory milestone under that
agreement.
COPD
COPD is a progressive disease which can cause obstruction of
airflow in the lungs resulting in debilitating bouts of
breathlessness.3 It
affects an estimated 384 million people4 and
is the third leading cause of death globally.5 Improving
lung function, reducing exacerbations and managing daily symptoms
such as breathlessness are important treatment goals in the
management of COPD.3 Even
a single COPD exacerbation may be associated with
a significant increase in the rate of decline in lung
function,6 a
significant deterioration in quality of life,7 and
can significantly reduce life expectancy and increase the risk of
mortality.8,9
ETHOS, KRONOS and the ATHENA clinical trial programme
ETHOS is a randomised, double-blinded, multi-centre,
parallel-group, 52-week trial to assess the efficacy and safety
of Breztri
Aerosphere in symptomatic
patients with moderate to very severe COPD and a history of
exacerbation(s) in the previous year. The primary endpoint was the
rate of moderate or severe exacerbations.1
KRONOS is a randomised, double-blinded, parallel-group, 24-week,
chronic-dosing, multi-centre trial to assess the efficacy and
safety of Breztri
Aerosphere in patients
with moderate to very severe COPD regardless of whether or not they
had an exacerbation in the previous year. The primary endpoints were lung function
parameters.2
ETHOS and KRONOS are part of AstraZeneca's ATHENA Phase III
clinical trial programme for Breztri
Aerosphere, which included more
than 15,500 patients globally across 11 trials.
Breztri Aerosphere
Breztri Aerosphere (budesonide/glycopyrrolate/formoterol
fumarate) is a single-inhaler, fixed dose triple-combination of
budesonide, an inhaled corticosteroid (ICS), with
glycopyrrolate, a long-acting muscarinic antagonist (LAMA),
and formoterol fumarate, a long-acting beta2-agonist (LABA),
delivered in a pressurised metered-dose
inhaler.
AstraZeneca in Respiratory & Immunology
Respiratory & Immunology is one of AstraZeneca's three
therapy areas and is a key growth driver for the
Company.
AstraZeneca is an established leader in respiratory care, and its
inhaled and biologic medicines reached more than 53 million
patients in 2019. Building on a 50-year heritage, the Company aims
to transform the treatment of asthma and COPD by focusing on
earlier biology-led treatment, eliminating preventable asthma
attacks, and removing COPD as a top-three leading cause of death.
The Company's early respiratory research is focused on emerging
science involving immune mechanisms, lung damage
and abnormal cell-repair processes in disease and
neuronal dysfunction.
With common pathways and underlying disease drivers across
respiratory and immunology, AstraZeneca is following the science
from chronic lung diseases to immunology-driven disease areas.
The Company's growing presence in immunology is focused on five
mid- to late-stage franchises with multi-disease potential, in
areas including rheumatology (including systemic lupus
erythematosus), dermatology, gastroenterology, and systemic
eosinophilic-driven diseases. AstraZeneca's ambition
in Respiratory & Immunology is to achieve disease
modification and durable remission for millions of patients
worldwide.
AstraZeneca
AstraZeneca (LSE/STO/NYSE: AZN) 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 and Metabolism, and Respiratory
& Immunology. Based in Cambridge, UK, AstraZeneca operates in
over 100 countries and its innovative medicines are used by
millions of patients worldwide. Please
visit astrazeneca.com and
follow the Company on Twitter @AstraZeneca.
Contacts
For details on how to contact the Investor Relations Team, please
click here.
For Media contacts, click here.
References
1.
Rabe KF, Martinez FJ, Ferguson
GT, et
al. Inhaled Triple Therapy
at Two Glucocorticoid Doses in Moderate-to-Very Severe
COPD. NEJM 2020; published on June 24, 2020, at
NEJM.org. DOI: 10.1056/NEJMoa191604.
2.
Ferguson GT, Rabe KF, Martinez
FJ, et
al. Triple combination of
budesonide/glycopyrrolate /formoterol fumarate using co-suspension
delivery technology versus dual therapies in chronic obstructive
pulmonary disease (KRONOS): a double-blind, parallel-group,
randomised controlled trial. Lancet Respir
Med. 2018; 6:
747-758.
3.
GOLD.
Global Strategy for the Diagnosis, Management and Prevention of
COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD)
2020. [Online]. Available at: http://goldcopd.org. [Last accessed:
July 2020].
4.
Adeloye D, Chua S, Lee C, et al. Global Health Epidemiology Reference Group
(GHERG). Global and regional estimates of COPD prevalence:
Systematic review and meta-analysis. J Glob
Health. 2015; 5 (2):
020415.
5.
Quaderi SA, Hurst JR.
The unmet global burden of COPD. Glob
Health Epidemiol Genom. 2018; 3: e4.
Published 2018 Apr 6. doi:10.1017/gheg.2018.1.
6.
Halpin DMG, Decramer M, Celli
BR, et
al. Effect of a single
exacerbation on decline in lung function in
COPD. Respiratory
Medicine 2017; 128:
85-91.
7.
Roche N, Wedzicha JA,
Patalano F, et
al. COPD
exacerbations significantly impact quality of life as measured by
SGRQ-C total score: results from the FLAME
study. Eur
Resp J. 2017; 50 (Suppl
61): OA1487.
8.
Ho TW, Tsai YJ, Ruan SY, et al. In-Hospital and One-Year Mortality and Their
Predictors in Patients Hospitalized for First-Ever Chronic
Obstructive Pulmonary Disease Exacerbations: A Nationwide
Population-Based Study. PLOS ONE. 2014; 9 (12): e114866.
9.
Suissa S, Dell'Aniello S, Ernst P. Long-term
natural history of chronic obstructive pulmonary disease: severe
exacerbations and mortality. Thorax. 2012; 67 (11): 957-63.
Adrian Kemp
Company Secretary
AstraZeneca PLC
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:
24 July
2020
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
|