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 November 2017
Commission
File Number: 001-11960
AstraZeneca PLC
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
AZ Fasenra receives
FDA approval for severe asthma
This announcement contains inside information
14 November 2017 22:45 GMT
FASENRA (BENRALIZUMAB)
RECEIVES US FDA APPROVAL
FOR SEVERE EOSINOPHILIC ASTHMA
Fasenra distinctively targets and rapidly depletes eosinophils and
is the first respiratory biologic with an 8-week maintenance dosing
schedule
FDA approval based on Phase III programme demonstrating up to 51%
reduction in asthma exacerbations, significant improvement in lung
function and a 75% reduction in daily oral steroid use
AstraZeneca
and its global biologics research and
development arm, MedImmune, today announced that the US Food and Drug
Administration (FDA) has approved Fasenra (benralizumab) for the add-on
maintenance treatment of patients with severe asthma aged 12 years
and older, and with an eosinophilic phenotype.
Pascal
Soriot, Chief Executive Officer of AstraZeneca, said: "We're
excited to offer Fasenra as
a new precision biologic to help improve the lives of severe asthma
patients whose disease is driven by eosinophilic inflammation. This
is the first approval from our respiratory biologics portfolio and
the latest in a series of significant milestones for our company as
we deliver on our pipeline-driven transformation."
The FDA approval is based on results from the WINDWARD programme,
including the pivotal Phase III exacerbation trials,
SIROCCO and
CALIMA, and the Phase III oral
corticosteroid (OCS)-sparing trial,
ZONDA. Results for the 8-week
benralizumab dosing regimen from these trials
showed:
●
Up to 51% reduction in the annual
asthma exacerbation rate (AAER) versus placebo
●
Significant improvement in lung
function as measured by forced expiratory
volume in one second (FEV1)
of up to 159mL versus placebo. Differences were seen as early as 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 that of placebo
Eugene
Bleecker, MD, Professor and Co-Director, Genetics, Genomics and
Precision Medicine, University of Arizona Health Sciences, and lead
investigator of the pivotal Phase III SIROCCO study, said: "This is
an important day for severe, eosinophilic asthma patients who have
had limited treatment options for far too long, with many relying
on oral steroids to manage their symptoms. Fasenra has a strong clinical profile
which includes the ability to show lung function improvement after
the first dose, the potential to reduce - or even stop - oral
steroid use, and the convenience of 8-week dosing. Fasenra also treats a distinct patient
phenotype, helping physicians select the right patient in clinical
practice with more confidence."
Fasenra 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.
Fasenra binds directly to the IL-5a receptor on an
eosinophil and uniquely attracts natural killer cells to induce
apoptosis (programmed cell death). Fasenra will be available as a once
every 8-week fixed-dose subcutaneous injection via a prefilled
syringe.
On 10 November, 2017, the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency
(EMA) adopted
a positive opinion recommending the marketing authorisation of
benralizumab. Benralizumab is also under regulatory review in Japan
and several other countries.
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 Fasenra
(benralizumab)
Fasenra 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 an early Phase II
trial. In the pivotal Phase III trials, SIROCCO and CALIMA,
Fasenra 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.
Fasenra will be available
as a subcutaneous injection via a prefilled syringe administered
once every 4 weeks for the first 3 doses, and then once every
8-weeks thereafter.
Fasenra is now approved in the
US, and under regulatory review in the EU, Japan and several other
countries.
Fasenra is the foundation of AstraZeneca's respiratory
biologics portfolio of potential new medicines targeting underlying
causes of respiratory disease. Fasenra is also being evaluated in
chronic obstructive pulmonary disease (COPD).
Fasenra was developed by AstraZeneca with 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 of 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 subcutaneous administration
of Fasenra (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 beta2-agonists) and
were randomised globally to receive either Fasenra 30mg every 4 weeks;
Fasenra 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 Fasenra efficacy and certain easily
identifiable clinical features of severe eosinophilic asthma,
including higher 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 Fasenra. Patients treated with Fasenra 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
Fasenra 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 Fasenra (anti-eosinophil,
anti-IL-5Rɑ), which is now approved in the US, received a
positive CHMP opinion in the EU and is under regulatory review in
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
Company Secretary
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:
14 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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