TIDMAZN
RNS Number : 1708N
AstraZeneca PLC
18 May 2020
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
trial(1) 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
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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(R) Handihaler(R) (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
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