Blueprint
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 September
2018
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.
Tezepelumab FDA Breakthrough Therapy
Designation
07 September 2018
Tezepelumab granted Breakthrough Therapy Designation by US
FDA
AstraZeneca's first Breakthrough Therapy Designation for a
respiratory medicine
Designation based on Phase IIb PATHWAY data that demonstrated
tezepelumab significantly reduced asthma exacerbations compared to
placebo in severe asthma
AstraZeneca and its partner Amgen Inc. (Amgen) today announced that
the US Food and Drug Administration (FDA) has granted Breakthrough
Therapy Designation for tezepelumab in patients with severe asthma,
without an eosinophilic phenotype, who are receiving inhaled
corticosteroids/long-acting beta2-agonists with or without oral
corticosteroids and additional asthma controllers.
A Breakthrough Therapy Designation is designed to expedite the
development and regulatory review of medicines that are intended to
treat a serious condition and that have shown encouraging early
clinical results, which may demonstrate substantial improvement on
a clinically-significant endpoint over available
medicines.
The Breakthrough Therapy Designation is based on the tezepelumab
Phase IIb PATHWAY data that showed a significant reduction
in the annual asthma exacerbation rate compared with placebo in a
broad population of severe asthma patients irrespective of patient
phenotype including Type 2 (T2) biomarker status. Currently-available biologic therapies only target
T2-driven inflammation. Tezepelumab is a potential first-in-class
new medicine that blocks thymic stromal lymphopoietin (TSLP)
- an upstream modulator of multiple inflammatory
pathways.
Sean Bohen, Executive Vice President, Global Medicines Development
and Chief Medical Officer at AstraZeneca, said: "Tezepelumab is
exciting because it has the potential to treat a broad population
of severe asthma patients, including those ineligible for
currently-approved biologic therapies. The Breakthrough Therapy
Designation will help us bring tezepelumab to patients as quickly
as possible."
This is the seventh Breakthrough Therapy Designation that
AstraZeneca has received from the FDA since 2014, and the first for
the Company in respiratory medicine. Tezepelumab is currently in
development in the Phase III PATHFINDER clinical trial
programme.
About Severe Asthma
Asthma
affects 334 million people worldwide, 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 oral corticosteroids (OCS). Severe
uncontrolled asthma is debilitating and potentially fatal with
patients experiencing frequent exacerbations and significant
limitations on lung function and quality of life.
Multiple
inflammatory pathways are involved in the pathogenesis of asthma.
T2 inflammation-driven asthma, which includes the eosinophilic
phenotype, is present in over two-thirds of patients with severe
asthma and is typically characterised by elevated levels of T2
inflammatory biomarkers, including blood eosinophils, serum IgE and
fractional exhaled nitric oxide (FeNO). Conversely, approximately
one-third of patients with severe asthma do not present with
increased T2 inflammation.
About Tezepelumab
Tezepelumab
is a potential first-in-class medicine blocking TSLP, an epithelial
cytokine, critical in the initiation and persistence of airway
inflammation. Blocking TSLP may prevent the release of
pro-inflammatory cytokines by immune cells resulting in the
prevention of asthma exacerbations and improved asthma control. Due
to its activity early in the inflammation cascade, tezepelumab may
be suitable for a broad population of patients with severe,
uncontrolled asthma, irrespective of patient phenotype including T2
biomarker status. Tezepelumab is being
developed by AstraZeneca in collaboration with
Amgen.
About the PATHWAY Phase IIb Trial
The PATHWAY Phase IIb data were published in the
New England Journal of Medicine and presented at the European Respiratory Society
International Congress in September 2017. The trial evaluated the
efficacy and safety of three dose regimens of tezepelumab as an
add-on therapy in patients with a history of asthma exacerbations
and uncontrolled asthma receiving inhaled
corticosteroids/long-acting beta2-agonists with or without oral
corticosteroids and additional asthma controllers, versus placebo.
The trial showed annual asthma exacerbation rate reductions of 62%,
71% and 66% in the tezepelumab arms receiving either 70mg or 210mg
every four weeks or 280mg every two weeks compared to placebo
(p<0.001 for all comparisons), respectively. These
results were observed independent of baseline blood eosinophil
count or other T2 inflammatory biomarkers. The most common adverse
events were asthma-related, nasopharyngitis, headaches and
bronchitis.
About the PATHFINDER Phase III Programme
Building on the PATHWAY Phase IIb trial, the PATHFINDER Phase III
programme was initiated in the fourth quarter of 2017 with two
pivotal trials: NAVIGATOR and SOURCE. The programme includes
additional planned mechanistic and long-term safety
trials.
NAVIGATOR is a Phase III multicentre, randomised, double-blinded,
parallel-group, placebo-controlled trial designed to evaluate the
efficacy and safety of a regular, subcutaneous administration of
tezepelumab for 52 weeks in adult and adolescent patients with
severe asthma inadequately controlled despite treatment with
inhaled corticosteroid (ICS) plus one additional asthma controller
medication.
SOURCE is a Phase III multicentre, randomised, double-blinded,
parallel-group, placebo-controlled trial for 48 weeks in adult
patients with severe asthma who require continuous treatment with
ICS plus long-acting beta2-agonists (LABA), and chronic treatment
with maintenance oral corticosteroid (OCS) therapy.
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 2017. 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-5rɑ), now approved for severe
eosinophilic asthma and in development for severe nasal polyposis,
and tezepelumab (anti-TSLP), which is in Phase III trials and
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 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 www.astrazeneca.com
and follow us on Twitter
@AstraZeneca.
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Adrian Kemp
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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:
07
September
2018
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By: /s/
Adrian Kemp
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Name:
Adrian Kemp
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Title:
Company Secretary
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