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2017-11-15

AstraZeneca: 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-5? 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
(https://www.astrazeneca.com/media-centre/press-releases/2017/benralizuma...)
recommending the marketing authorisation of benralizumab.
Benralizumab is also under regulatory review in Japan and several
other countries.

- ENDS -

NOTES TO EDITORS

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-5R?), 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.

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