TIDMAZN
RNS Number : 2861W
AstraZeneca PLC
26 April 2016
BEVESPI AEROSPHERE(TM) APPROVED BY
THE US FDA for PATIENTS WITH COPD
Demonstrated superior improvement in lung function versus
mono-components and placebo
Only long-acting dual bronchodilator delivered through a
pressurised metered-dose inhaler (pMDI) and first product to use
AstraZeneca's patented Co-Suspension(TM) Technology
AstraZeneca has announced that the US Food and Drug
Administration has approved Bevespi Aerosphere (glycopyrrolate and
formoterol fumarate) inhalation aerosol indicated for the
long-term, maintenance treatment of airflow obstruction in patients
with chronic obstructive pulmonary disease (COPD), including
chronic bronchitis and/or emphysema.
Sean Bohen, Executive Vice-President, Global Medicines
Development and Chief Medical Officer, said: "With the approval of
Bevespi Aerosphere we are pleased to provide patients with the
first LAMA/LABA in a pressurised metered-dose inhaler, delivered
using our unique formulation technology. LAMA/LABAs are emerging as
a preferred treatment option for many COPD patients. This class
aims to provide maximum bronchodilation, which enables patients to
breathe better and may help them be more active."
Bevespi Aerosphere is a twice-daily, fixed-dose dual
bronchodilator combining glycopyrrolate, a long-acting muscarinic
antagonist (LAMA), and formoterol fumarate, a long-acting beta-2
agonist (LABA). The FDA approval is based on the PINNACLE trial
programme, which demonstrated that Bevespi Aerosphere achieved
statistically significant improvement in morning pre-dose forced
expiratory volume in 1 second (FEV1) at 24 weeks (p<0.001)
versus its mono-components and placebo.
Bevespi Aerosphere is the first product approved using
AstraZeneca's Co-Suspension Technology. This technology enables
consistent delivery of one or more different medicines from a
single pMDI. The technology is being applied to a range of
AstraZeneca respiratory inhaled combination therapies currently in
clinical development, such as the fixed-dose triple combination of
LAMA/LABA/Inhaled corticosteroid (PT010).
About COPD
COPD (chronic obstructive pulmonary disease) is a progressive
disease associated mainly with tobacco smoking, air pollution or
occupational exposure, which can cause obstruction of airflow in
the lungs resulting in debilitating bouts of breathlessness. It
affects an estimated 329 million people worldwide and is predicted
to be the third leading cause of death by 2030. Improving lung
function and managing daily symptoms such as breathlessness are
important to the management of COPD. It is estimated that eight out
of 10 patients suffer symptoms at night, such as an irritative
cough and difficulty breathing, frequent nocturnal awakenings,
which leads to insomnia, worry and anxiety.
About AstraZeneca's Co-Suspension Technology
The Co-Suspension Technology uses porous, low-density
phospholipid particles, which are designed to form a uniform
suspension inside a pressurised metered-dose inhaler (pMDI) and
distribution of drug crystals throughout the lungs for release at
their sites of deposition.
In addition, Co-Suspension Technology addresses issues often
seen when multiple drugs are combined in a pMDI. This technology
provides a stable, homogeneous suspension designed to prevent
sedimentation of drug crystals over time and to prevent drug
crystals from interacting with one another, thus allowing for
consistent dosing of one or more different drugs from a single
pMDI.
About the PINNACLE studies
The FDA approval of Bevespi Aerosphere is based on data from the
PINNACLE 1, PINNACLE 2, and a safety extension study, PINNACLE 3.
Overall the Phase III pivotal programme enrolled over 3,700
patients with moderate to very severe COPD.
Bevespi Aerosphere demonstrated statistically significant
improvements in lung function as measured by change from baseline
in morning pre-dose trough forced expiratory volume in 1 second
(FEV1) at 24 weeks (p<0.001) versus its individual components
(glycopyrrolate 9 mcg and formoterol fumarate 4.8 mcg) and placebo,
all dosed twice daily.
Bevespi Aerosphere demonstrated a significant improvement versus
placebo on secondary endpoints of peak FEV1 within 2 hours
post-dose, and rescue medication usage.
There were no unexpected safety findings with adverse events
consistent with previous results from the development program. The
most common adverse reactions with Bevespi Aerosphere, (with a
>= 2% incidence and more common than with placebo) were urinary
tract infection (2.6% vs 2.3% with placebo) and cough (4.0% vs 2.7%
with placebo).
About Respiratory, Inflammation and Autoimmunity Diseases
Respiratory, Inflammation and Autoimmunity (RIA), one of
AstraZeneca's main therapy areas, has five potential medicines in
pivotal trials or under registration. In respiratory disease, our
aim is to transform asthma and COPD treatment through: Inhaled
combinations at the core of care, precision biologics for the unmet
needs of specific patient populations, and scientific advancements
in disease modification. We are building on a 40-year heritage in
respiratory disease, and our capability in inhalation technology
spans both pressurised metered-dose inhalers (pMDIs) and dry powder
inhalers (DPIs), as well as our unique Co-Suspension
Technology.
In Inflammation and Autoimmunity, our aim is to develop
innovative therapies for the treatment of autoimmune and rheumatoid
diseases, with a lead programme in systemic lupus erythematosus.
Across respiratory, inflammation and autoimmune diseases, our
research is focused on four key treatable traits: eosinophilic
disease, Th2-driven disease, epithelial-driven pathobiology, and
autoimmunity.
About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical
business that focuses on the discovery, development and
commercialisation of prescription medicines, primarily for the
treatment of diseases in three main therapy areas - respiratory,
inflammation, autoimmune disease (RIA), cardiovascular and
metabolic disease (CVMD) and oncology - as well as in infection and
neuroscience. 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
CONTACTS
Media Enquiries
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+44 20 7604
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+46 8 553 260
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Investor Enquiries
UK
Thomas Kudsk Larsen +44 7818 524185
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Nick Stone CVMD +44 7717 618834
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Christer Gruvris Consensus Forecasts +44 7827 836825
US
Lindsey Trickett Oncology, ING +1 240 543 7970
Mitch Chan Oncology +1 240 477 3771
Dial / Toll-Free +1 866 381 7277
Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD -
Cardiovascular and Metabolic Disease,
ING - Infection, Neuroscience and Gastrointestinal
26 April 2016
-ENDS-
This information is provided by RNS
The company news service from the London Stock Exchange
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