a1711n
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 May 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.
Bevespi Aerosphere
approved in China for COPD
18 May 2020 07:00 BST
Bevespi
Aerosphere approved in
China for patients with COPD
First approval in China of a fixed-dose, long-acting
dual
bronchodilator in a pressurised metered-dose inhaler
device
AstraZeneca's Bevespi
Aerosphere (glycopyrronium/formoterol fumarate) has
been approved in China as a maintenance treatment to relieve
symptoms in patients with chronic obstructive pulmonary disease
(COPD), including chronic bronchitis and/or
emphysema.
The approval by the National Medical Products
Administration (NMPA) was based on positive results from
the Phase III PINNACLE 4 trial1 in
which Bevespi
Aerosphere demonstrated a
statistically significant improvement in lung function as measured
by trough forced expiratory volume in one second (FEV1), compared
to its monotherapy components and placebo, all administered twice
daily via pressurised metered-dose inhaler (pMDI) in patients with
moderate to very severe COPD. The trial formed part of the broader
PINNACLE clinical trials programme showing efficacy and safety and
involving more than 5,000 patients across Asia, Europe and the
US.2,3,4
This was the first approval by the NMPA for a maintenance,
fixed-dose, long-acting dual bronchodilator combination therapy in
a pMDI, which uses the innovative Aerosphere delivery technology.
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&D, said: "Chronic obstructive pulmonary disease affects
almost 100 million people in China and presents a significant
patient and public health burden. The use of maintenance
combination therapies in China is increasing year-on-year and the
approval of Bevespi
Aerosphere offers an
important new treatment and choice of inhaler for patients,
particularly those with limited lung function and advanced age who
may benefit from using a pressurised metered-dose
inhaler."
Bevespi Aerosphere is
already approved in the US, EU, Japan and other countries for the
long-term maintenance treatment of moderate to very severe
COPD.
The approval of Bevespi
Aerosphere follows the
recent approval of AstraZeneca's triple-combination
therapy, Breztri
Aerosphere (budesonide/glycopyrronium/formoterol
fumarate), for the maintenance treatment of COPD in
China.5
COPD
COPD is a progressive disease which can cause obstruction of
airflow in the lungs resulting in debilitating bouts of
breathlessness.6 It
affects an estimated 384 million people worldwide and approximately
100 million people in China.7,8 COPD
is the third leading cause of death globally.6 Improving
lung function, reducing exacerbations and managing daily symptoms
such as breathlessness are important treatment goals in the
management of COPD.6
PINNACLE
PINNACLE 1, 2 and 4 were randomised, double-blinded, multi-centre,
placebo-controlled trials conducted over 24 weeks, which compared
the efficacy and safety of Bevespi
Aerosphere administered
twice daily via a pMDI to its monotherapy components
(glycopyrronium and formoterol fumarate) and to
placebo.1,2,3 In
PINNACLE 1, open-label tiotropium was included as an active
control.2 PINNACLE
3 was a multi-centre, randomised, double-blinded, parallel-group,
chronic-dosing, active-controlled, 28-week safety extension trial
of PINNACLE 1 and 2, which evaluated the long-term safety,
tolerability and efficacy of Bevespi
Aerosphere administered
twice daily via a pMDI compared to its monotherapy
components.4 All
the trials were conducted in patients with moderate to very severe
COPD.1,2,3,4
Results from the PINNACLE 4 trial were published
in the International
Journal of Chronic Obstructive Pulmonary Disease.1
Bevespi Aerosphere
Bevespi Aerosphere (glycopyrronium/formoterol fumarate) is a
fixed-dose dual bronchodilator in a pMDI, combining glycopyrronium,
a long-acting muscarinic antagonist (LAMA), and formoterol
fumarate, a long-acting beta2-agonist (LABA). PMDIs are an
important choice for COPD patients where limited lung function,
advanced age and reduced dexterity or cognition are significant
considerations for patients to achieve therapeutic benefits from
their medicines.9,10 Bevespi
Aerosphere is the only
LABA/LAMA with Aerosphere delivery technology. Results from an imaging
trial have shown that Bevespi
Aerosphere effectively
delivers medicine to both the large and small
airways.11
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 lupus), 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. Lipworth B, Collier DJ, Gon Y, et
al. Improved lung function and patient-reported outcomes with
co-suspension delivery technology glycopyrrolate/formoterol
fumarate metered dose inhaler in COPD: a randomized Phase III study
conducted in Asia, Europe, and the USA. Int J Chron Obstruct Pulmon
Dis. 2018; 13:
2969-2984.
2.
Clinicaltrials.gov. Efficacy and Safety of PT003, PT005, and PT001
in Subjects With Moderate to Very Severe Chronic Obstructive
Pulmonary Disease (COPD);(PINNACLE 1). [Online]. Available at:
https://clinicaltrials.gov/ct2/show/NCT01854645. [Last accessed:
May 2020].
3.
Clinicaltrials.gov. Multi-Center Study to Assess the Efficacy and
Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very
Severe COPD (PINNACLE 2). [Online]. Available at:
https://clinicaltrials.gov/ct2/show/NCT01854658. [Last accessed:
May 2020].
4.
Clinicaltrials.gov. Extension Study to Evaluate the Safety and
Efficacy of PT003, PT001, and PT005 in Subjects With Moderate to
Very Severe COPD, With Spiriva® Handihaler® (PINNACLE 3).
[Online]. Available at:
https://clinicaltrials.gov/ct2/show/NCT01970878. [Last accessed:
May 2020].
5.
AstraZeneca PLC. AstraZeneca's triple-combination therapy approved
in China for patients with COPD. [Online].
https://www.astrazeneca.com/media-centre/press-releases/2019/astrazenecas-triple-combination-therapy-approved-in-china-for-patients-with-copd-23122019.html.
[Last accessed: May 2020].
6.
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: May 2020].
7. 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.
8. Wang C, Xu J, Yang L, Xu Y,
Zhang X, Bai C, et al. Prevalence and risk factors of chronic
obstructive pulmonary disease in China (the China Pulmonary Health
[CPH] study): a national cross-sectional study. Lancet. 2018;391:1706-1717.
9. Usmani O, Capstick T, Chowhan
H, et
al. Inhaler choice
guideline. March 2017 [Online]. Available at:
https://www.guidelines.co.uk/respiratory/inhaler-choice-guideline/252870.article.
[Last accessed: May 2020].
10. Bonini M and Usmani OS. The importance
of inhaler devices in the treatment of
COPD. COPD Res
Pract.
2015;1:9.
11. AstraZeneca
PLC. Aerosphere delivery
technology - Global Core Claims Guide.
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:
18 May 2020
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
|