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AstraZeneca: Fasenra receives approval in Japan

Approval based on Phase III WINDWARD programme that demonstrated

reductions in asthma exacerbations, improvements in lung function and
reductions in

oral corticosteroid use from baseline, versus placebo
Fasenra is the first approved respiratory biologic with an 8-week
maintenance dosing schedule

AstraZeneca and its global biologics research and development arm,
MedImmune, today announced that the Japanese Ministry of Health,
Labour and Welfare has approved Fasenra (benralizumab) as an add-on
treatment for bronchial asthma in patients who continue to experience
asthma exacerbations despite treatment with high-dose inhaled
corticosteroid and other asthma controllers.

The approval is based on the results from the WINDWARD programme,
including the pivotal Phase III exacerbation trials, SIROCCO
and the Phase III oral corticosteroid (OCS)-sparing trial, ZONDA
Fasenra will be available as a fixed-dose subcutaneous injection in a
prefilled syringe administered once every four weeks for the first
three doses, and then once every eight weeks thereafter.1

Sean Bohen, Executive Vice President, Global Medicines Development and
Chief Medical Officer at AstraZeneca, said: "The approval of Fasenra,
our first respiratory biologic medicine, in Japan closely follows the
recent US and EU decisions and brings us another step closer to
achieving our ambition of transforming care for severe asthma
patients around the world."

Fasenra binds directly to the IL-5? receptor on eosinophils, a type of
white blood cell that are a normal part of the body's immune system,2
and attracts natural killer cells to induce direct, rapid and
near-complete depletion of eosinophils via apoptosis (programmed cell
death).5,6,7 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

The Japanese approval follows US FDA approval in November 2017 and
European Commission marketing authorisation in January 2018.
Interactions with regulatory authorities in the rest of the world are

- ENDS -


About Severe Asthma

Asthma affects approximately 315 million individuals worldwide. 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.3,9,10

Severe, uncontrolled asthma is debilitating and potentially fatal with
patients experiencing frequent exacerbations and significant
limitations on lung function and quality of life.11,12,13 Severe,
uncontrolled asthma has higher risk of mortality than severe

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.10,15,16,17,18 There is also a significant
physical and socio-economic burden of severe, uncontrolled asthma
with these patients accounting for 50% of asthma-related costs.19

About Fasenra (benralizumab)

Fasenra is a monoclonal antibody that recruits natural killer cells to
induce direct, rapid and near-complete depletion of eosinophils.7,20
Depletion of circulating eosinophils is rapid, with an onset of
action within 24 hours as confirmed in early Phase I/II
trials.7,20,21 Eosinophils are the biological effector cells in
approximately 50% of asthma patients, leading to frequent
exacerbations, impaired lung function and asthma symptoms.3,4

Fasenra is now approved in the US, EU and Japan, and under regulatory
review in several other jurisdictions.

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) with data readout expected in
the second half of 2018.22

Fasenra was developed by AstraZeneca with MedImmune, the company'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,
pivotal trials SIROCCO
are randomised, double-blinded, parallel-group, placebo-controlled
trials designed to evaluate the efficacy and safety of a regular,
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.5,6

A total of 2,510 patients (1,204 in SIROCCO and 1,306 in CALIMA)
received standard-of-care medicines (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.5,6,23

In SIROCCO and CALIMA, patients with severe, uncontrolled eosinophilic
asthma receiving Fasenra experienced a significant reduction in
asthma exacerbations and improvement in their lung function and
asthma symptoms compared to patients receiving placebo, on top of
their standard medicines.5,6 The most commonly reported adverse
reactions during treatment were headache (8%) and pharyngitis (3%).
Other common adverse reactions included fever, hypersensitivity
reactions and injection site reactions.1,5,6

A pooled post-hoc analysis of the SIROCCO and CALIMA trials,
demonstrated an association between enhanced Fasenra 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

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. The results were published in the New England
Journal of Medicine
( in May 2017.24

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 COPD.22

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's biologics include
Fasenra, (anti-eosinophil, anti-IL-5r?), which is now approved in the
US, EU, Japan, and is under regulatory review in other jurisdictions,
and tezepelumab (anti-TSLP), which successfully achieved its Phase
IIb primary and secondary endpoints and has initiated Phase III.
AstraZeneca's research is focused on addressing underlying disease
drivers focusing on the lung epithelium, lung immunity and lung

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 commercialisation 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, Calif. For
more information, please visit

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 and follow us
on Twitter @AstraZeneca.

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