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 2017
Commission File
Number: 001-11960
AstraZeneca
PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge CB2
0AA
United
Kingdom
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This announcement contains inside information
28 February 2017 07:00 GMT
FDA APPROVES ONCE-DAILY QTERN (DAPAGLIFLOZIN AND SAXAGLIPTIN)
TABLETS FOR ADULTS WITH TYPE-2 DIABETES
Qtern fixed-dose combination will provide an additional oral
medicine option for patients taking Farxiga (dapagliflozin) to
improve blood sugar level
AstraZeneca
today announced that the US Food and Drug Administration (FDA) has
approved once-daily Qtern
(10mg dapagliflozin and 5mg saxagliptin) for the treatment of
type-2 diabetes. The new medicine is indicated as an adjunct to
diet and exercise to improve glycaemic (blood sugar level) control
in adults with type-2 diabetes who have inadequate control with
dapagliflozin (10mg) or who are already treated with dapagliflozin
and saxagliptin.
Elisabeth Björk, Vice President, Head of Cardiovascular and
Metabolic Diseases, Global Medicines Development at AstraZeneca,
said: "Type-2 diabetes is a complex disease that is at epidemic
proportions, affecting more than 29 million people in the
US alone.
The approval of Qtern is good news for patients who may benefit from
improved glycaemic control by adding a DPP-4 inhibitor to a SGLT-2
inhibitor in a convenient once-daily tablet."
SGLT-2
inhibitors help patients achieve improved glycaemic control by
reducing the reabsorption of glucose from the blood and enabling
its removal via the urine. SGLT-2
inhibitors, including Farxiga (dapagliflozin), have demonstrated reductions in
HbA1c and have also been shown to reduce weight and blood pressure.
DPP-4 inhibitors reduce blood glucose as measured by
HbA1c.
About Qtern
Qtern combines two anti-hyperglycaemic agents with
complementary mechanisms of action in a once-daily tablet:
Dapagliflozin, a sodium-glucose cotransporter 2 (SGLT-2) inhibitor;
and saxagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor. The
FDA approved Qtern based on
data from a 24-week, Phase III, multi-centre, randomised,
double-blind, placebo-controlled trial (n=315) designed to evaluate
the efficacy and safety of saxagliptin added to dapagliflozin in
adult patients with type-2 diabetes who experienced inadequate
glycaemic control (HbA1c ≥7% to ≤10.5%) with metformin
(≥1,500mg per day). The safety
of combined use of dapagliflozin and saxagliptin has been evaluated
in a pooled safety analysis (N=1,169; 492 treated with
Qtern) of three Phase III placebo-controlled
clinical trials for up to 52 weeks.
About AstraZeneca in Diabetes
AstraZeneca is pushing the boundaries of science with the goal of
developing life-changing medicines that aim to reduce the global
burden and complications of diabetes. As a core therapy area for
the company, we are focusing our research and development efforts
on diverse populations and patients with significant
co-morbidities, such as cardiovascular disease, obesity,
non-alcoholic steatohepatitis (NASH), and chronic kidney
disease.
Our commitment to diabetes is exemplified by the depth and breadth
of our global clinical research programme. This commitment is
advancing understanding of the treatment effects of our diabetes
medicines in broad patient populations, as well as exploring
combination product approaches to help more patients achieve
treatment success earlier in their disease progression. Our
ambition is to reduce the long-term impact of
diabetes.
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 main therapy areas - Oncology, Cardiovascular &
Metabolic Diseases and
Respiratory. The Company also is selectively active in the areas of
Autoimmunity, Neuroscience and Infection. 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
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.
AstraZeneca
PLC
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Date:
28 February 2017
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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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