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 December
2018
Commission
File Number: 001-11960
AstraZeneca PLC
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Bevespi Aerosphere approved in the EU for COPD
20 December 2018 13:45 GMT
Bevespi
Aerosphere approved in
the EU for chronic obstructive pulmonary
disease
AstraZeneca today announced that the European Commission (EC) has
approved Bevespi
Aerosphere(glycopyrronium/formoterol fumarate) in a
pressurised metered-dose inhaler (pMDI) as a maintenance dual
bronchodilator treatment to relieve symptoms in adult patients with
chronic obstructive pulmonary disease
(COPD). Bevespi
Aerosphere is the first
medicine in its class to be approved by the EC in a pMDI. The
approval offers patients with COPD an important new choice of
inhaler device.
Dr Colin Reisner, Head of Respiratory, Global Medicines
Development, said: "Bevespi
Aerosphere is already
available to COPD patients in the US and other countries, and this
approval means we can now bring this new medicine to patients in
Europe. Bevespi Aerosphere is the first dual-bronchodilator treatment
delivered in our next-generation pressurised metered-dose inhaler
using Aerosphere Delivery Technology."
Dr Omar Usmani, Consultant Physician in Respiratory Medicine at the
National Heart & Lung Institute, Imperial College London
and Royal Brompton Hospital, UK, said: "Bevespi
Aerosphere is an important
treatment option in COPD, particularly for patients with limited
lung function and advanced age who may benefit from using a
pMDI. The efficacy and safety profile
of Bevespi
Aerosphere has been well
established in the Phase III PINNACLE
programme."
Bevespi Aerosphere is a
twice-daily, fixed-dose dual bronchodilator
combining glycopyrronium, a long-acting muscarinic antagonist
(LAMA), and formoterol fumarate, a long-acting beta2-agonist
(LABA). The EC approval is based on the Phase III PINNACLE trial
programme which evaluated the efficacy and safety
of Bevespi
Aerosphere and involved
more than 5,000 patients with moderate to very-severe
COPD.
Bevespi Aerosphere is also
approved in the US, Canada, Australia, Turkey and Taiwan as a dual
bronchodilator for the long-term maintenance treatment of
COPD.
About COPD
COPD is a progressive disease which can cause obstruction of
airflow in the lungs resulting in debilitating bouts of
breathlessness.1 It
affects an estimated 384 million people worldwide and is predicted
to be the third leading cause of death by 2020.1,2 Improving
lung function, reducing exacerbations and managing daily symptoms
such as breathlessness are important treatment goals in the
management of COPD.1
About the Phase III PINNACLE programme
PINNACLE 1/2/4 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, compared to its monotherapy components
(glycopyrronium and formoterol fumarate) and to
placebo.3,4,5 In
PINNACLE 1, open-label tiotropium was included as an active
control.3PINNACLE
3 was a multi-centre, randomised, double-blinded, parallel-group,
chronic-dosing, active-controlled, 28-week safety extension trial
of PINNACLE 1/2, which evaluated the long-term safety,
tolerability, and efficacy of Bevespi
Aerosphere administered
twice daily via a pMDI compared to its monotherapy
components.6 All
the trials were conducted in patients with moderate to very-severe
COPD.
About Bevespi
Aerosphere
Bevespi Aerosphere is a
fixed-dose dual bronchodilator combining glycopyrronium, a
long-acting muscarinic antagonist (LAMA), and formoterol fumarate,
a long-acting beta2-agonist (LABA) in a pMDI. Pressurised
metered-dose inhalers 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.7,8 Bevespi
Aerosphere is the only
LAMA/LABA with AerosphereDelivery Technology. Results from an imaging trial
have shown that Bevespi
Aerosphere effectively
delivers medicine to both the large and small
airways.9 Aerosphere Delivery
Technology is also the platform for the potential new medicine
PT010, AstraZeneca's triple combination of budesonide
/glycopyrronium/formoterol fumarate.
About AstraZeneca in Respiratory Disease
Respiratory disease is one of AstraZeneca's main
therapy areas, and the Company has a growing portfolio of medicines
that reached more than 18 million patients in 2017. 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),
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
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AstraZeneca PLC
References
1. GOLD.
Global Strategy for the Diagnosis, Management and Prevention of
COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD)
2018. [Online]. Available at: http://goldcopd.org. Last accessed:
November 2018.
2. 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.
3.
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:
November 2018.
4.
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:
November 2018.
5. AstraZeneca plc.
Bevespi Aerosphere demonstrates statistically significant
improvement in lung function in patients with COPD. [Online].
Available at: https://www.astrazeneca.com/media-centre/press-releases/2017/bevespi-aerosphere-demonstrates-statistically-significant-improvement-in-lung-function-in-patients-with-copd-25092017.html Last
accessed: November 2018
6.
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:
November 2018.
7. 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: November 2018.
8.
Bonini and Usmani. The importance of inhaler devices in the
treatment of COPD. COPD Research & Practice. 2015: 1:
9
9.
AstraZeneca. Aerosphere Delivery Technology - Global Core Claims
Guide.
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:
20 December
2018
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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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