RNS Number : 7455O
04 October 2019
04 October 2019 07:00 BST
Fasenra approved in the US for self-administration
in a new pre-filled auto-injector, the Fasenra Pen
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
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. The safety and tolerability of Fasenra
in these trials were consistent with the established profile of the
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
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.
About GRECO and AMES
GRECO is a Phase III multicentre, 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 30mg dose of Fasenra administered subcutaneously (SC)
every four weeks in clinic and in an at--home setting in 120 adults
with severe, uncontrolled asthma.(1) 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 multicentre, randomised, open-label, parallel-group
Phase I trial in healthy people to compare the pharmacokinetic (PK)
exposure following single 30mg SC administration of Fasenra by
using pre-filled syringe or pre-filled auto-injector devices.(2)
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-type 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.(1)
(--) AMES: nasopharyngitis, headache, oropharyngeal pain.(2)
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 professional decides 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 simple 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.
Fasenra 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).(3,4)
Fasenra is AstraZeneca's first respiratory biologic, now
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 30mg SC injection via a
pre-filled, single-use syringe or as the Fasenra Pen, both with a
thin 29-gauge needle, administered once every four weeks for the
first three doses and once every eight weeks thereafter.
Fasenra is also in development for severe nasal polyposis, other
eosinophilic diseases, and chronic obstructive pulmonary disease
(COPD). The FDA granted Orphan Drug Designation to Fasenra for the
treatment of eosinophilic granulomatosis with polyangiitis (EGPA)
in November 2018, hypereosinophilic syndrome (HES) in February 2019
and eosinophilic oesophagitis (EoE) in August 2019.
Fasenra was developed by AstraZeneca and is in-licensed from
BioWa, Inc., a wholly-owned subsidiary of Kyowa Kirin Co., Ltd.,
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
pressurised 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 5R 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.
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, 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
astrazeneca.com and follow us on Twitter @AstraZeneca.
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1. Barker P, Ferguson GT, Cole J, et al. Single-use autoinjector
functionality and reliability for at-home benralizumab
administration: GRECO trial results. J Allergy Clin Immunol.
2019;143 (2) Supplement, page AB96.
2. Martin U, Fuhr R, Forte P, et al. Comparison of accessorized
pre-filled syringe with autoinjector for benralizumab
pharmacokinetic exposure in healthy volunteers following
administration of a single subcutaneous dose: AMES trial results. J
Allergy Clin Immunol. 2019;143 (2) Supplement, page AB95.
3. Kolbeck R, Kozhich A, Koike M, et al. MEDI-563, a humanized
anti-IL-5 receptor a mAb with enhanced antibody-dependent
cell-mediated cytotoxicity function. J Allergy Clin Immunol. 2010
4. Pham TH, Damera G, Newbold P, Ranade K. Reductions in
eosinophil biomarkers by benralizumab in patients with asthma.
Respir Med. 2016; 111:21-29.
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