TIDMAZN
RNS Number : 5114W
AstraZeneca PLC
14 November 2017
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 (FEV(1) ) 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<ALPHA> 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 beta(2) -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.
For more information, please visit www.astrazeneca.com and
follow us on Twitter @AstraZeneca.
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AstraZeneca PLC
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