TIDMAZN
RNS Number : 9313D
AstraZeneca PLC
01 July 2019
1 July 2019 07:00 BST
Fasenra receives positive EU CHMP opinion for
self-administration
and the new Fasenra pen, a pre-filled, single-use
auto-injector
AstraZeneca today announced that the European Medicines Agency's
Committee for Medicinal Products for Human Use (CHMP) has issued a
positive opinion to add a self-administration option for Fasenra
(benralizumab) and a new delivery method as a pre-filled,
single-use auto-injector (the Fasenra pen) to the medicine's
product information in the European Union.
The CHMP opinion can be implemented without the need for a
European Commission decision due to the nature of the Type-II label
variation.
The positive opinion for self-administration and the Fasenra pen
is supported by the Phase III GREGALE and GRECO trials, and the
Phase I AMES trial, respectively. The safety and tolerability of
Fasenra in these trials were consistent with the known profile of
the medicine.
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&D, said: "Fasenra is the only respiratory biologic medicine
that can be administered every eight weeks after the initial
loading-dose period, and this positive opinion means we are closer
to offering Fasenra in a way that is even more convenient for many
patients. We hope self-administration and the Fasenra pen will play
important roles in helping physicians make treatment with biologic
medicines accessible to more people with severe eosinophilic
asthma."
AstraZeneca anticipates a regulatory decision by the US Food and
Drug Administration (FDA) on self-administration and the new
pre-filled, single-use auto-injector device in the second half of
2019. Fasenra is currently approved as an add-on maintenance
treatment for severe eosinophilic asthma in the US, EU, Japan and
other countries.
About self-administration and the Fasenra pen
Fasenra will be available as both a fixed 30mg subcutaneous
injection via a pre-filled, single-use syringe or 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.
The new 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.
About the GREGALE, GRECO and AMES trials
GREGALE is a Phase III, multicentre, open-label, 28-week,
functionality, reliability and performance trial of 30mg Fasenra
administered subcutaneously (SC) every four weeks in clinic and at
home through week 16 with a pre-filled syringe in 120 adult
patients with severe, uncontrolled asthma.(1) The majority of
patients and caregivers successfully administered Fasenra at home
using a pre-filled syringe at week 12 (98%) and week 16 (99%). The
majority of returned pre-filled syringes (99%) used to administer
at home were considered functional at week 12 and week 16.
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 SC every four weeks
in clinic and in an at--home setting in 120 adults with severe,
uncontrolled asthma.(2) The majority (97%) of at-home
administrations by patients or caregivers were successful at week
12 and week 16 and nearly all (96%) returned pre-filled
auto-injector devices used to administer Fasenra at home were
evaluated as functional at week 12 and week 16. The majority (97%)
of at-home administrations by patients or caregivers were
successful at week 12 and week 16. Nearly all (96%) returned
auto-injector devices used to administer Fasenra at home were
evaluated as functional at week 12 and week 16.
AMES is a multicentre, randomised, open-label, parallel group
Phase I trial in healthy subjects to compare the pharmacokinetic
(PK) exposure following single 30mg SC administration of Fasenra by
using pre-filled syringe or pre-filled auto-injector devices.(3)
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 all three 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; GREGALE - nasopharyngitis, upper respiratory
tract infection, headache, sinusitis; AMES - nasopharyngitis,
headache, oropharyngeal pain.(1,2,3)
About Fasenra
Fasenra (benralizumab) is a monoclonal antibody that binds
directly to 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).(19,20)
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 several other countries, with
further regulatory reviews ongoing. Fasenra is also in development
for severe nasal polyposis, other eosinophilic diseases, and
chronic obstructive pulmonary disease. The FDA granted Orphan Drug
Designation for Fasenra for the treatment of eosinophilic
granulomatosis with polyangiitis (EGPA) in November 2018 and
hypereosinophilic syndrome (HES) in February 2019.
Fasenra was developed by AstraZeneca and is in-licensed from
BioWa, Inc., a wholly-owned subsidiary of Kyowa Hakko 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
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 US
Food and Drug Administration 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 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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References
1. Study to Assess Functionality, Reliability, and Performance
of a Pre-filled Syringe With Benralizumab Administered at Home
(GREGALE). ClinicalTrials.gov.
https://clinicaltrials.gov/ct2/show/NCT02417961. Accessed 17 April
2019.
2. Study to Assess Functionality, Reliability, and Performance
of a Single-Use Auto-Injector With Benralizumab Administered at
Home (GRECO). ClinicalTrials.gov.
https://clinicaltrials.gov/ct2/show/NCT02918071. Accessed 17 April
2019.
3. Pharmacokinetic Comparability of Benralizumab Using
Accessorized Pre-Filled Syringe or Autoinjector in Healthy
Volunteers. ClinicalTrials.gov.
https://clinicaltrials.gov/ct2/show/NCT02968914. Accessed 17 April
2019.
4. Chanez P, Humbert M. European respiratory review: Asthma:
still a promising future? European Respiratory Review. 2014, 23
(134) 405-407.
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Last accessed April 2018.
19. Kolbeck R, Kozhich A, Koike M, et al. MEDI-563, a humanized
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cell-mediated cytotoxicity function. J Allergy Clin Immunol. 2010
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