TIDMAZN
RNS Number : 5204B
AstraZeneca PLC
10 January 2018
10 January 2018 15:10 GMT
FASENRA RECEIVES EU APPROVAL FOR SEVERE EOSINOPHILIC ASTHMA
Approval based on Phase III WINDWARD programme that demonstrated
significant reductions in asthma exacerbations, improvements in
lung function and reductions in oral corticosteroid use from
baseline, versus placebo
Fasenra is the first-ever approved respiratory biologic medicine
with an 8-week maintenance dosing schedule
AstraZeneca and its global biologics research and development
arm, MedImmune, today announced that the European Commission (EC)
has approved Fasenra (benralizumab) as an add-on maintenance
treatment in adult patients with severe eosinophilic asthma
inadequately controlled despite high-dose inhaled corticosteroids
plus long-acting beta-agonists.(1)
The approval is based on the results from the WINDWARD
programme, including the pivotal Phase III exacerbation trials,
SIROCCO and CALIMA, and the Phase III OCS-sparing trial,
ZONDA.(1)
Sean Bohen, Executive Vice President, Global Medicines
Development and Chief Medical Officer at AstraZeneca, said:
"Fasenra is our first respiratory biologic medicine. Today's
decision from the EC follows the recent approval of Fasenra in the
US and is another positive step towards our ambition to transform
care for severe asthma patients whose disease is driven by
eosinophilic inflammation."
Tim Harrison, Professor of Asthma and Respiratory Medicine,
University of Nottingham, UK, and investigator in the WINDWARD
trial programme, said: "Many patients with severe eosinophilic
asthma experience debilitating symptoms and face increased risk of
emergency room visits, hospitalisations and death, despite current
treatments. I look forward to being able to offer Fasenra as a new
anti-eosinophilic monoclonal antibody which has demonstrated
efficacy versus placebo in pivotal clinical trials and has the
convenience of an 8-week maintenance dosing regimen."
Eosinophils are a type of white blood cell that are a normal
part of the body's immune system.(2) 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.(3,4) Fasenra binds directly to the
IL-5<ALPHA> receptor on an eosinophil and attracts natural
killer cells to induce apoptosis (programmed cell death).(5,6,7)
Fasenra will be available as a fixed-dose subcutaneous injection
via a prefilled syringe administered once every 4 weeks for the
first 3 doses, and then once every 8 weeks thereafter.(1)
In November 2017, the US Food and Drug Administration (FDA)
approved Fasenra for the add-on maintenance treatment of patients
with severe asthma aged 12 years and older, and with an
eosinophilic phenotype.(8) Fasenra is also under regulatory review
in Japan and several other countries, with expected regulatory
decisions in H1 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.(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 asthma.(12,14)
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
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 and EU, and under regulatory
review in 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).(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, including SIROCCO, CALIMA, ZONDA, BISE, BORA and
GREGALE.(22) 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.(5,6)
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 b(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.(5,6,23)
In SIROCCO and CALIMA, patients with severe, uncontrolled
eosinophilic asthma receiving Fasenra experienced significant
reduction in asthma exacerbations and improved lung function and
asthma symptoms compared to patients receiving placebo, on top of
their standard treatments.(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 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.(23)
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. 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 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 Aerosphere
Delivery Technology. The company's biologics include Fasenra,
(anti-eosinophil, anti-IL-5r ), which is now approved in the US and
EU and is under regulatory review in Japan and other countries,
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
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, 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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References
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