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 August
2018
Commission
File Number: 001-11960
AstraZeneca PLC
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
AstraZeneca
PIIIb trial update for Bevespi in COPD
23
August 2018 07:00 BST
AstraZeneca provides update on AERISTO Phase IIIb trial
for
Bevespi Aerosphere in
chronic obstructive pulmonary disease
AstraZeneca today announced top-line results from the AERISTO Phase
IIIb trial for Bevespi Aerosphere
(glycopyrronium/formoterol fumarate)
in patients with moderate to very severe chronic obstructive
pulmonary disease (COPD). In the trial, Bevespi Aerosphere
demonstrated non-inferiority to
umeclidinium/vilanterol on peak forced expiratory volume in one
second (FEV1) but did not demonstrate superiority on peak FEV1 or
non-inferiority on trough FEV1.
Dr
Colin Reisner, Head of Respiratory, Global Medicines Development,
said: "The efficacy and safety of Bevespi Aerosphere has been established
by the Phase III PINNACLE trial programme involving more than 5,000
patients. The performance of Bevespi Aerosphere in AERISTO is
inconsistent with previous data. A full analysis is underway to
understand and characterise these findings and will be presented at
a forthcoming medical meeting."
The 24-week AERISTO Phase IIIb trial was a randomised,
double-blinded, double-dummy, multicentre, parallel-group trial
designed to assess the efficacy and safety of Bevespi Aerosphere
compared with umeclidinium/vilanterol.
The primary endpoints were peak change from baseline in FEV1 where
non-inferiority and superiority were measured and change from
baseline in trough FEV1 where non-inferiority was measured. In the
trial, 1,119 patients were randomised to receive either two
inhalations twice a day of Bevespi Aerosphere
(glycopyrronium/formoterol fumarate
7.2/4.8µg) via pressurised metered-dose inhaler or one
inhalation once a day of umeclidinium/vilanterol 62.5/25µg via
dry powder inhaler. Safety and tolerability data for
Bevespi
Aerosphere were consistent with
the known profile of the medicine.
Bevespi Aerosphere is approved
in the US and Canada for the long-term maintenance treatment of
airflow obstruction in COPD. Bevespi Aerosphere
is currently under review by the
European Medicines Agency with a regulatory decision anticipated in
the second half of 2018.
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
At initial diagnosis, approximately one-third of COPD patients have
severe or very severe forms of the disease.3 Improving lung
function, reducing exacerbations and managing daily symptoms such
as breathlessness are important to the management of
COPD.1 Moderate to severe COPD is typically managed
through long-acting bronchodilator therapy. Despite the
availability of effective long-acting bronchodilator monotherapies,
many patients remain symptomatic and may require dual long-acting
bronchodilator therapy.1,4
About Bevespi
Aerosphere
Bevespi Aerosphere is a fixed-dose dual bronchodilator
combining glycopyrronium, a long-acting muscarinic agonist (LAMA),
and formoterol fumarate, a long-acting beta2-agonist (LABA).
Bevespi Aerosphere is the first and only
LAMA/LABA with Aerosphere
Delivery Technology. Results from an imaging trial have shown that
Bevespi Aerosphere
effectively delivers medicine to both the large and small
airways.5
Aerosphere Delivery
Technology is also the platform for potential new medicines
including 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), now approved for severe eosinophilic asthma and
in development for severe nasal polyposis, and tezepelumab
(anti-TSLP), which achieved its Phase IIb primary and secondary
endpoints and is continuing development in the Phase III PATHFINDER
clinical trial programme. 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 www.astrazeneca.com
and follow us on Twitter
@AstraZeneca.
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Adrian Kemp
Company Secretary
AstraZeneca PLC
References
1.
Global Strategy for the Diagnosis, Management and Prevention of
COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD)
2018. Available from: http://goldcopd.org. Last accessed June
2018.
2.
Mapel DW, Anand AD, Blanchette CM et al. Severity of COPD at
initial spirometry-confirmed diagnosis: data from medical charts
and administrative claims. Int J Chron Obstruct Pulmon Dis.
2011;6:573-81. doi: 10.2147/COPD.S16975.
3. Cazzola et al. The scientific
rationale for combining long-acting beta2-agonists and muscarinic
antagonists in COPD. Pulm Pharmacol
Ther. 2010:
23(4):257-67
4. Pedersen S et al. Influence of
inspiratory flow rate upon the effect of a Turbuhaler.
Arch Dis
Child.
1990;65:308-10
5.
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:
23
August
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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