Form 6-K ASTRAZENECA PLC For: Jul 09
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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 July
2020
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F X Form 40-F __
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(1):
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(7): ______
Indicate
by check mark whether the registrant by furnishing the information
contained in this Form is also thereby furnishing the information
to the Commission pursuant to Rule 12g3-2(b) under the Securities
Exchange Act of 1934.
Yes __
No X
If
“Yes” is marked, indicate below the file number
assigned to the Registrant in connection with Rule 12g3-2(b):
82-_____________
AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Brilinta
granted US FDA Priority Review for
stroke
9 July 2020 07:00 BST
Brilinta granted FDA Priority Review for the
reduction of subsequent stroke
in patients who had an acute ischemic stroke or transient ischemic
attack
Brilinta in combination with aspirin could be the first
FDA-approved dual
antiplatelet therapy to reduce the rate of stroke in these
high-risk patients
AstraZeneca today announced the US Food and Drug Administration
(FDA) has accepted a supplemental New Drug Application (sNDA) and
granted Priority Review for Brilinta (ticagrelor) for the reduction of
subsequent stroke in patients who experienced an acute ischemic
stroke or transient ischemic attack (TIA).
The Prescription Drug User Fee Act date, the FDA action date for
this supplemental application, is scheduled for the fourth quarter
of 2020.
The sNDA was based on results from the Phase III THALES trial,
which showed aspirin plus Brilinta 90mg used twice daily for 30 days resulted
in a statistically significant and clinically meaningful reduction
in the risk of the primary composite endpoint of stroke and death,
compared to aspirin alone.1 The
results were in line with the known safety profile
of Brilinta.1
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&D, said: "Patients who have had an acute ischaemic stroke or
transient ischemic attack are at high risk of experiencing a
subsequent stroke, which may be disabling or fatal. Today's
Priority Review reflects Brilinta's potential as a much-needed treatment option to
reduce the rate of subsequent stroke for these patients and we look
forward to working with the FDA to make Brilinta available as soon as
possible."
The data from the THALES trial will be published in a peer reviewed
journal and presented at an forthcoming medical
congress.
Brilinta is approved in
more than 110 countries for the prevention of atherothrombotic
events in adult patients with acute coronary syndrome (ACS) and in
more than 70 countries for the secondary prevention of
cardiovascular events among high-risk patients who have experienced
a heart attack. In May 2020, the FDA approved
a label
update for Brilinta in the US to include the reduction of the
risk of a first heart attack or stroke in high-risk patients with
coronary artery disease.
Stroke
Stroke is the second leading cause of death worldwide, with 6.2
million stroke-related deaths in 2017, of which 2.7 million were
due to ischaemic stroke.2 Patients
who experience an acute ischaemic stroke or TIA are at high risk of
developing subsequent ischaemic events, with particularly high risk
within 30 days after the initial event and the highest risk period
being the first 24 hours after the initial
event.3
THALES
THALES is an AstraZeneca sponsored, randomised, placebo-controlled,
double-blinded, international, multicentre, event-driven trial
involving more than 11,000 patients from 28 countries. It tested
the hypothesis whether aspirin plus Brilinta is superior to aspirin alone in preventing
the composite of stroke and death in patients with
non-cardioembolic acute ischaemic stroke or high-risk TIA. Patients
were randomised within 24 hours of onset of acute ischaemic stroke
or high-risk TIA symptoms and followed-up for 30 days of treatment.
Trial treatments were Brilinta 180mg loading dose on day 1 as soon as
possible after randomisation, followed by 90mg twice daily on days
2-30, or matching placebo. All patients received open-label aspirin
300-325mg on day 1, followed by 75-100mg once daily on days
2-30. The primary efficacy outcome was the time to the
composite endpoint of stroke and death at 30 days. The primary
safety outcome is time to first severe bleeding event according to
the Global Utilization of Streptokinase and Tissue Plasminogen
Activator for Occluded Coronary Arteries (GUSTO) definition,
which includes fatal bleedings, intracranial haemorrhage; and
bleeding causing hemodynamic compromise requiring intervention.
Patients were followed for an additional 30 days on standard of
care.
Brilinta
Brilinta (ticagrelor) is
an oral, reversible, direct-acting P2Y12 receptor antagonist that
works by inhibiting platelet activation. Brilinta, together with aspirin, has been shown to
significantly reduce the risk of major adverse cardiovascular
events (myocardial infarction, stroke or cardiovascular death), in
patients with ACS or a history of myocardial infarction (MI, heart
attack).
Brilinta, co-administered with
aspirin, is indicated for the prevention of atherothrombotic events
in adult patients with ACS, or for patients with a history of MI
and a high risk of developing an atherothrombotic
event.
AstraZeneca in CVRM
Cardiovascular, Renal and Metabolism (CVRM) together forms one of
AstraZeneca's three therapy areas and is a key growth driver for
the Company. By following the science to understand more clearly
the underlying links between the heart, kidneys and pancreas,
AstraZeneca is investing in a portfolio of medicines to protect
organs and improve outcomes by slowing disease progression,
reducing risks and tackling comorbidities. The Company's ambition
is to modify or halt the natural course of CVRM diseases and
potentially regenerate organs and restore function, by continuing
to deliver transformative science that improves treatment practices
and cardiovascular health for millions of patients
worldwide.
AstraZeneca
AstraZeneca (LSE/STO/NYSE: AZN) 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
& Immunology. Based in Cambridge, UK, AstraZeneca operates in
over 100 countries and its innovative medicines are used by
millions of patients worldwide. Please
visit astrazeneca.com and
follow the Company on Twitter @AstraZeneca.
Contacts
For details on how to contact the Investor Relations Team, please
click here.
For Media contacts, click here.
References
1.
AstraZeneca: https://otp.tools.investis.com/clients/uk/astrazeneca/rns/regulatory-story.aspx?cid=1343&newsid=1361096].
2. Roth GA et al. Global, regional, and national
age-sex-specific mortality for 282 causes of death in 195 countries
and territories, 1980-2017: A systematic analysis for the Global
Burden of Disease Study 2017. The Lancet 2018;
392(10159):1736-88.
3. Khanevski AN, et al. Thirty-day recurrence after ischemic stroke
or TIA. Brain Behav 2018; 8(10):e01108.
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.
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AstraZeneca
PLC
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Date:
09 July
2020
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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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