WILMINGTON, Del., Nov. 14, 2017 /PRNewswire/ -- AstraZeneca
(NYSE: AZN) 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. FASENRA is not
approved for the treatment of other eosinophilic conditions or
relief of acute bronchospasm or status
asthmaticus.
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."
Experience the interactive Multimedia News Release here:
https://www.multivu.com/players/English/8204951-astrazeneca-fasenra-fda-approval/
The FDA approval is based on results from the WINDWARD program,
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 159 mL
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.
Adverse events with an incidence greater than or equal to 3% were
headache, pyrexia, pharyngitis and hypersensitivity
reactions
Eugene R. 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,
as observed in a Phase II study. 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-5α receptor on an eosinophil
and uniquely attracts natural killer cells to induce apoptosis
(programmed cell death). 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.
Karen Kempley, severe,
eosinophilic asthma patient, said: "Most people don't appreciate
the simple act of breathing until they can't do it. As someone with
severe asthma, I know how devastating it is to not have control
over your asthma and to live with the fear of not knowing when your
next asthma attack might happen. When you can't breathe, you can't
do the things you want or need to do – like go to work or be with
your family – and that impacts every aspect of your life."
FASENRA will be available in the US within the coming weeks.
AstraZeneca recognizes patients may need assistance accessing
FASENRA. FASENRA360 provides a range of support services for
patients on FASENRA including access and reimbursement support,
affordability programs for eligible patients, nursing support for
FASENRA questions, and ongoing patient education. Eligible
commercially insured patients may pay as little as $0 for FASENRA and as little as $0 for its injection
administration. For more information, please call
1-833-360-HELP or visit www.FASENRA.com.
On November 10, 2017, the
Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) adopted a positive opinion
recommending the marketing authorization of benralizumab.
Benralizumab is also under regulatory review in Japan and several other countries.
INDICATION
FASENRA is indicated for the add-on maintenance treatment of
patients with severe asthma aged 12 years and older, and with an
eosinophilic phenotype.
- FASENRA is not indicated for treatment of other eosinophilic
conditions
- FASENRA is not indicated for the relief of acute bronchospasm
or status asthmaticus
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Known hypersensitivity to
benralizumab or excipients.
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions
Hypersensitivity reactions
(eg, anaphylaxis, angioedema, urticaria, rash) have occurred after
administration of FASENRA. These reactions generally occur within
hours of administration, but in some instances have a delayed onset
(ie, days). Discontinue in the event of a hypersensitivity
reaction.
Acute Asthma Symptoms or Deteriorating Disease
FASENRA
should not be used to treat acute asthma symptoms, acute
exacerbations, or acute bronchospasm.
Reduction of Corticosteroid Dosage
Do not discontinue
systemic or inhaled corticosteroids abruptly upon initiation of
therapy with FASENRA. Reductions in corticosteroid dose, if
appropriate, should be gradual and performed under the direct
supervision of a physician. Reduction in corticosteroid dose may be
associated with systemic withdrawal symptoms and/or unmask
conditions previously suppressed by systemic corticosteroid
therapy.
Parasitic (Helminth) Infection
It is unknown if
FASENRA will influence a patient's response against helminth
infections. Treat patients with pre-existing helminth infections
before initiating therapy with FASENRA. If patients become infected
while receiving FASENRA and do not respond to anti-helminth
treatment, discontinue FASENRA until infection resolves.
ADVERSE REACTIONS
The most common adverse reactions
(incidence ≥ 5%) include headache and pharyngitis.
Injection site reactions (eg, pain, erythema, pruritus, papule)
occurred at a rate of 2.2% in patients treated with FASENRA
compared with 1.9% in patients treated with placebo.
USE IN SPECIFIC POPULATIONS
The data on pregnancy
exposure from the clinical trials are insufficient to inform on
drug-associated risk. Monoclonal antibodies such as benralizumab
are transported across the placenta during the third trimester of
pregnancy; therefore, potential effects on a fetus are likely to be
greater during the third trimester of pregnancy.
Please read full Prescribing Information, including Patient
Information.
You are encouraged to report negative side effects of
prescription drugs to the FDA.
Visit www.FDA.gov/medwatch or
call 1-800-FDA-1088.
NOTES TO EDITORS
About Severe Asthma
Asthma affects 24 million
individuals in the US, 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 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 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 Program
The WINDWARD program 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 randomized, 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
randomized globally and received either benralizumab 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 program 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-5Rɑ), 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 commercialization of prescription medicines,
primarily for the treatment of diseases in three main 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-us.com and follow us on Twitter
@AstraZenecaUS.
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