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FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
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Report
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For the
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2017
Commission
File Number: 001-11960
AstraZeneca PLC
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This announcement contains inside information
10 November 2017 11:35 GMT
BENRALIZUMAB RECEIVES POSITIVE EU CHMP OPINION
FOR SEVERE, UNCONTROLLED EOSINOPHILIC
ASTHMA
Benralizumab
uniquely targets and rapidly depletes eosinophils and is the first
respiratory biologic with an 8-week maintenance dosing
schedule
Recommendation based on extensive Phase III programme demonstrating
significant reductions in exacerbations, improvements in lung
function and
reductions in oral steroid use, respectively
AstraZeneca
and its global biologics research and development arm, MedImmune,
today announced that the Committee for Medicinal Products for Human
Use (CHMP) of the European Medicines Agency has adopted a positive
opinion, recommending the marketing authorisation of benralizumab
as an add-on maintenance treatment in adult patients with severe
eosinophilic asthma inadequately controlled despite high-dose
inhaled corticosteroids plus long-acting
-agonists.
Sean
Bohen, Executive Vice President, Global Medicines Development and
Chief Medical Officer at AstraZeneca, said: "This positive
recommendation is an important step towards providing a
next-generation treatment for severe, uncontrolled asthma patients
with an eosinophilic phenotype. Benralizumab has the potential to
make a real difference to patients with its combination of
efficacy, speed of onset, convenience and the ability to reduce
oral steroid use."
The CHMP recommendation is based on results from the WINDWARD
programme, including the pivotal Phase III exacerbation
trials, SIROCCO
and CALIMA,
and Phase III oral corticosteroid (OCS)-sparing trial,
ZONDA.
Results for the 8-week dosing benralizumab regimen from these
trials showed:
●
Up to 51% reduction in the annual
asthma exacerbations rate (AERR) versus placebo
●
Rapid improvement in lung function
(290mL increase in forced expiratory volume in one second
(FEV1)
from baseline at 4 weeks) after the first dose, providing an early
indication of effectiveness
●
75% median
reduction in daily OCS use and discontinuation of OCS use in 52% of
eligible patients
●
An overall
adverse event profile similar to placebo
Tim
Harrison, Professor of Asthma and Respiratory Medicine, University
of Nottingham, UK, and CALIMA trial investigator, said: "Severe,
uncontrolled asthma affects millions of people around the world,
and many patients experience debilitating symptoms and face
increased risk of hospitalisations, emergency room visits and death
despite current treatments. Benralizumab is a new kind of precision
antibody with proven efficacy and ease of use which will help
transform severe asthma care."
Benralizumab
is the only respiratory biologic that provides direct, rapid and
near-complete depletion of eosinophils within 24 hours. Eosinophils
are a type of white blood cell that are a normal part of the body's
immune system. Elevated levels of eosinophils, seen in about half
of severe asthma patients, impact airway inflammation and airway
hyper-responsiveness, resulting in increased asthma severity and
symptoms, decreased lung function and increased risk of
exacerbations.
Benralizumab
binds directly to the IL-5a receptor on an eosinophil and uniquely
attracts natural killer cells to induce apoptosis (programmed cell
death). If approved, benralizumab will be available as a once every
8-week fixed-dose subcutaneous injection via a prefilled
syringe.
A
recent pooled analysis of the SIROCCO and CALIMA trials identified
specific, well-defined characteristics of an eosinophilic phenotype
that will allow clinicians to more precisely select the severe
asthma patients most likely to receive maximum benefit from
treatment with benralizumab.
The
positive opinion from the CHMP will now be reviewed by the European
Commission, which has the authority to approve medicines for the 28
EU member countries plus Iceland, Norway and
Liechtenstein.
Benralizumab
is also under regulatory review in the US, Japan and several other
countries, with a US PDUFA date during the fourth quarter of 2017
and expected regulatory decisions elsewhere during the first half
of 2018.
About Severe Asthma
Asthma
affects 315 million individuals worldwide, and up to 10% of asthma
patients have severe asthma, which may be uncontrolled despite high
doses of standard-of-care asthma controller medicines and can
require the use of chronic OCS.
Severe, uncontrolled asthma is debilitating and potentially fatal
with patients experiencing frequent exacerbations and significant
limitations on lung function and quality of life. Severe,
uncontrolled asthma has higher risk of mortality than severe
asthma.
Severe,
uncontrolled asthma can lead to a dependence on OCS, with systemic
steroid exposure potentially leading to serious short- and
long-term adverse effects, including weight gain, diabetes,
osteoporosis, glaucoma, anxiety, depression, cardiovascular disease
and immunosuppression. There is also a significant physical and
socio-economic burden of severe, uncontrolled asthma with these
patients accounting for 50% of asthma-related costs.
About Benralizumab
Benralizumab
is a monoclonal antibody that recruits natural killer cells to
induce direct, rapid and near-complete depletion of eosinophils.
Depletion of circulating eosinophils is rapid, with an onset of
action within 24 hours as confirmed in early Phase I/II trials. In
the pivotal Phase III trials, SIROCCO and CALIMA, benralizumab
demonstrated significant reduction in exacerbations and improved
lung function and asthma symptoms in severe, uncontrolled
eosinophilic asthma patients. Eosinophils are the biological
effector cells in approximately 50% of asthma patients, leading to
frequent exacerbations, impaired lung function and asthma symptoms.
Benralizumab is not approved anywhere in the world, but is under
regulatory review in the US, EU, Japan and several other
countries.
Benralizumab is
the foundation of AstraZeneca's respiratory biologics portfolio of
potential new medicines targeting underlying causes of respiratory
disease. Benralizumab is also being evaluated in chronic
obstructive pulmonary disease (COPD).
Benralizumab
was developed by MedImmune, AstraZeneca's global biologics research
and development arm and is in-licensed from BioWa, Inc., a
wholly-owned subsidiary of Kyowa Hakko Kirin Co., Ltd.,
Japan.
About the WINDWARD Programme
The WINDWARD programme in asthma is made up six Phase III trials,
including SIROCCO, CALIMA, ZONDA, BISE, BORA and GREGALE. The two
pivotal trials SIROCCO
and CALIMA,
are randomised, double-blinded, parallel-group, placebo-controlled
trials designed to evaluate the efficacy and safety of a regular,
subcutaneous administration of benralizumab (fixed 30mg dose) for
up to 56-weeks in exacerbation-prone adult and adolescent patients
12 years of age and older.
A total
of 2,510 patients (1,204 in SIROCCO and 1,306 in CALIMA) received
standard-of-care medicine (including high-dosage inhaled
corticosteroids and long-acting 2-agonists) and
were randomised globally to receive either benralizumab 30mg every
4-weeks; benralizumab 30mg every 4-weeks for the first three doses
followed by 30mg every 8-weeks; or placebo administered via
subcutaneous injection using an accessorised pre-filled
syringe.
A
recent pooled post hoc
analysis of the SIROCCO and CALIMA studies, demonstrated an
association between enhanced benralizumab efficacy and certain
easily identifiable clinical features of severe eosinophilic
asthma, including baseline blood eosinophil counts, history of more
frequent exacerbations, chronic OCS use and a history of nasal
polyposis.
The third registrational trial, ZONDA,
demonstrated a statistically-significant and clinically-meaningful
reduction in daily-maintenance, OCS use compared with placebo for
patients with severe, uncontrolled OCS-dependent eosinophilic
asthma receiving benralizumab. Patients treated with benralizumab
achieved a median reduction in OCS dose of 75%, and were more than
four times as likely to reduce their OCS dose than those on
placebo. The results were published in
the New England Journal of Medicine in May 2017.
In
addition to WINDWARD, the Phase III VOYAGER programme is currently
underway, which is evaluating the efficacy and safety of
benralizumab in patients with severe, chronic obstructive pulmonary
disease (COPD).
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 2016. 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 both
pMDIs and dry powder inhalers, as well as the innovative Aerosphere
Delivery Technology. The company's biologics include benralizumab
(anti-eosinophil, anti-IL-5rɑ), which has been accepted for
regulatory review in the US, EU and Japan, tralokinumab
(anti-IL-13), which has completed Phase III trials, and tezepelumab
(anti-TSLP), which successfully achieved its Phase IIb primary and
secondary endpoints. AstraZeneca's research is focused on
addressing underlying disease drivers focusing on the lung
epithelium, lung immunity and lung regeneration.
About MedImmune
MedImmune is the global biologics research and development arm of
AstraZeneca, a global, innovation-driven biopharmaceutical business
that focuses on the discovery, development and commercialization of
small molecule and biologic prescription medicines. MedImmune is
pioneering innovative research and exploring novel pathways across
Oncology, Respiratory, Cardiovascular & Metabolic Diseases, and
Infection and Vaccines. The MedImmune headquarters is located in
Gaithersburg, Md., one of AstraZeneca's three global R&D
centres, with additional sites in Cambridge, UK and Mountain View,
CA. For more information, please visit www.medimmune.com
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 & Metabolic
Diseases and Respiratory. The Company also is selectively active in
the areas of autoimmunity, neuroscience and infection. 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
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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:
10 November 2017
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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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