FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of October
2019
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Fasenra
approved in the US for self-administration
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
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 FasenraPen).
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 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."
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 Fasenraby 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.
About Fasenra
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., 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 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 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.
Media
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References
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
Jun;125(6):1344-1353.e2.
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.
Adrian Kemp
Company Secretary
AstraZeneca PLC
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
Date:
04 October
2019
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
|