TIDMAZN
RNS Number : 1876W
AstraZeneca PLC
10 November 2017
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 b-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 (FEV(1) ) 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-5<ALPHA> 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 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.
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-5r ), 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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AstraZeneca PLC
This information is provided by RNS
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