FASENRA is now the only respiratory biologic
that offers the choice of administration at home or in a doctor’s
office with eight-week maintenance dosing
AstraZeneca today announced that the US Food and Drug
Administration (FDA) has approved the self-administration of
FASENRA® (benralizumab) in a pre-filled, single-use auto-injector
(the FASENRA Pen™).
The approval is supported by data from the Phase III GRECO trial
and the Phase I AMES trial, which achieved their primary objective
of usability and pharmacokinetic (PK) exposure, respectively. The
safety and tolerability of FASENRA in these trials were consistent
with the established profile of the medicine.
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&D, said: “FASENRA is the only respiratory biologic that can
be given every eight weeks after the initial loading-dose period.
Today’s news means we can now offer FASENRA in an even more
convenient way, giving US healthcare providers and patients the
option of administering FASENRA at home or in a doctor’s office,
and making treatment more accessible to patients with severe
eosinophilic asthma.”
Reynold Panettieri, MD, Vice Chancellor for Translational
Medicine and Science and Director of Rutgers Institute for
Translational Medicine and Science, said: “As a clinician, I use
FASENRA in my office because of its efficacy and safety data. The
importance of this approval is that my patients and I now have
another option to personalize their treatment approach to help meet
their needs and fit their lifestyle.”
FASENRA self-administration and the FASENRA Pen are also
approved in the European Union (EU). FASENRA is currently approved
as an add-on maintenance treatment for severe eosinophilic asthma
in the US, EU, Japan and other countries.
FASENRA is not approved for the treatment of other eosinophilic
conditions or 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 A pregnancy exposure registry
monitors pregnancy outcomes in women exposed to FASENRA during
pregnancy. To enroll call 1-877-311-8972 or visit
www.mothertobaby.org/fasenra.
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.
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
Please read full Prescribing Information, including Patient
Information.
About GRECO and AMES GRECO is a Phase III multicenter,
open‑label, 28-week trial designed to assess patient‑ or
caregiver‑reported functionality, performance and reliability of a
pre-filled auto-injector device with a fixed 30 mg dose of FASENRA
administered subcutaneously (SC) every four weeks in clinic and in
an at‑home setting in 120 adults with severe, uncontrolled asthma.
The majority (97%) of at-home administrations by patients or
caregivers were successful at week 12 and week 16 and nearly all
(96%) of the returned pre-filled auto-injector devices used to
administer FASENRA at home were evaluated as being functional at
week 12 and week 16.
AMES is a multicenter, randomized, open-label, parallel group
Phase I trial in healthy people to compare the pharmacokinetic (PK)
exposure following single 30 mg SC administration of FASENRA by
using pre-filled syringe or pre-filled auto-injector devices.
FASENRA PK exposure was comparable following SC administration via
a pre-filled syringe or a pre-filled auto-injector. Eosinophils
were rapidly depleted in patients from both device groups.
The safety profile in both trials was similar to previous
trials, with no new or unexpected safety findings. The most common
adverse events observed in each trial were:
- GRECO: viral upper respiratory tract infection, asthma, upper
respiratory tract infection, headache
- AMES: nasopharyngitis, headache, oropharyngeal pain
About the FASENRA Pen The US approval of the
FASENRA Pen provides healthcare professionals and patients the
option for FASENRA to be administered outside of a clinical setting
via auto-injector by a patient or caregiver after their healthcare
provider determines it is appropriate. The FASENRA pre-filled
syringe is available for administration by a healthcare
professional.
The FASENRA Pen enables patients and caregivers to administer
the medicine via a two-step process. The device includes a viewing
window and audible clicks at the start and end of the injection to
guide patients with successful administration.
About FASENRA FASENRA® (benralizumab) is a
monoclonal antibody that binds directly to the IL-5 receptor alpha
on eosinophils and attracts natural killer cells to induce rapid
and near-complete depletion of eosinophils via apoptosis
(programmed cell death).
FASENRA is AstraZeneca’s first respiratory biologic, approved as
an add-on maintenance treatment in severe eosinophilic asthma in
the US, EU, Japan and other countries, with further regulatory
reviews ongoing. Where approved for self-administration, FASENRA
will be available both as a fixed-dose 30 mg SC via a pre-filled,
single-use syringe or as the FASENRA Pen, both with a 29-gauge
needle, administered once every four weeks for the first three
doses and once every eight weeks thereafter.
FASENRA was developed by AstraZeneca and is in-licensed from
BioWa, Inc., a wholly owned subsidiary of Kyowa Kirin Co., Ltd.,
Japan.
About AstraZeneca in respiratory diseases Respiratory is
one of AstraZeneca’s three therapy areas, and our medicines reached
more than 18 million patients as maintenance therapy in 2018.
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
pressurized metered-dose inhalers and dry powder inhalers, as well
as the AEROSPHERE™ Delivery Technology. The company also has a
growing portfolio of respiratory biologics including FASENRA
(anti-eosinophil, anti-IL-5 receptor alpha), and tezepelumab
(anti-TSLP) which has been granted Breakthrough Therapy Designation
by the FDA in patients with severe asthma and is in Phase III
trials. AstraZeneca’s research aims at addressing underlying
disease drivers by focusing on the lung epithelium, lung immunity,
lung regeneration and neuronal functions.
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 therapy areas -
Oncology, Cardiovascular, Renal & Metabolism, and Respiratory.
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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