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 February
2019
Commission
File Number: 001-11960
AstraZeneca PLC
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Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Forxiga receives positive EU CHMP
opinion
1 February 2019 1:15pm GMT
Forxiga receives
positive EU CHMP opinion
for the treatment of adults with type-1 diabetes
Forxiga is the first oral medicine recommended for approval in
Europe
as an adjunct treatment to insulin for adults with type-1
diabetes
The Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) has recommended a new indication
for the marketing authorisation of Forxiga (dapagliflozin), after adopting a positive
opinion for use as an oral adjunct treatment to insulin in adults
with type-1 diabetes (T1D).
Forxiga, a selective sodium
glucose cotransporter-2 (SGLT2) inhibitor, is the first oral
medicine to receive a positive recommendation from the EMA for use
in T1D as an adjunct to insulin in patients with BMI ≥ 27
kg/m2, when insulin alone does not provide adequate glycaemic
control despite optimal insulin therapy. The positive opinion is
based on Phase III data from the DEPICT
(Dapagliflozin Evaluation in Patients
With Inadequately Controlled Type 1-Diabetes) clinical
programme.
Elisabeth Björk, Vice President, Head of Cardiovascular, Renal
and Metabolism, BioPharmaceuticals, said: "People with type-1
diabetes have not seen oral treatment innovation in decades
and we believe today's announcement signals an important
advancement for them, as well as a broader understanding of the
well-established clinical profile of Forxiga for people living with metabolic
diseases."
The DEPICT clinical programme consists of two trials, DEPICT-1 and
-2, with the primary efficacy endpoint at 24 weeks and a long-term
extension up to 52 weeks. Both trials demonstrated
that Forxiga, when given as an oral adjunct to adjustable
insulin in adults with inadequately-controlled T1D, showed
significant reductions from baseline in HbA1c (primary endpoint),
weight and total daily insulin dose (secondary endpoints) at 24 and
52 weeks, vs. placebo, at both 5mg and 10mg
doses.1,2,3
Forxiga is also under
regulatory review in the US and Japan for use as adjunct treatment
to insulin in adults with T1D.
About the DEPICT clinical programme
The DEPICT clinical trial programme consists of two clinical
trials: DEPICT-1 (NCT02268214) and DEPICT-2 (NCT02460978). DEPICT-1
and DEPICT-2 are 24-week, randomised, double-blinded,
parallel-controlled trials designed to assess the effects
of Forxiga 5mg or 10mg on glycaemic control in patients
with T1D inadequately controlled by insulin. All patients were
evaluated at week 24 and after a 28-week extension (52 weeks in
total).
About Forxiga
Forxiga (dapagliflozin) is
a first-in-class, oral once-daily selective inhibitor of human
sodium-glucose co-transporter 2 (SGLT2) indicated as both
monotherapy and as part of combination therapy to improve glycaemic
control, with the additional benefits of weight loss and blood
pressure reduction, as an adjunct to diet and exercise in adults
with T2D. Forxiga has a robust clinical trial programme of
more than 35 completed and ongoing Phase IIb/III trials in over
35,000 patients, as well as more than 1.8 million patient-years'
experience.
About AstraZeneca in Cardiovascular, Renal & Metabolism
(CVRM)
Cardiovascular, renal and metabolism together form one of
AstraZeneca's main therapy areas and 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 co-morbidities. Our 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.
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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Adrian Kemp
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AstraZeneca PLC
References
1. Dandona P,
Mathieu C, Phillip M, et al. Efficacy and safety of dapagliflozin
in patients with inadequately controlled type 1 diabetes
(DEPICT-1): 24-week results from a randomised controlled
trial. Lancet Diabetes
and Endocrinol. http://dx.doi.org/10.1016/PII.
Published Online September 14, 2017.
2. Mathieu
C, Dandona, P, Gillard, P, et al. Efficacy and Safety of
Dapagliflozin in Patients With Inadequately Controlled Type 1
Diabetes (the DEPICT-2 Study): 24-Week Results From a Randomized
Controlled Trial. Diabetes Care 2018;41:1938-1946.
3. Dandona
P, Mathieu C, Phillip M, et al. Efficacy and safety of
dapagliflozin in patients with inadequately controlled type 1
diabetes: The Depict-1 52-week study. Diabetes Care 2018 Dec;
41(12): 2552-2559.
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:
01 February
2019
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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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