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Form 6-K ASTRAZENECA PLC For: Jul 19

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July 19, 2016 1:01 PM EDT
 
 
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 2016
 
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-_____________
 
 
 
This announcement contains inside information
 
19 July 2016 14:15
 
ASTRAZENECA RECEIVES APPROVAL IN THE EU FOR QTERN (SAXAGLIPTIN AND DAPAGLIFLOZIN) FOR TREATMENT OF TYPE 2 DIABETES
 
AstraZeneca today announced that the European Commission (EC) has approved Qtern (saxagliptin/dapagliflozin) tablets for the treatment of type 2 diabetes in all 28 EU member countries plus Iceland, Liechtenstein and Norway. The fixed-dose combination of saxagliptin and dapagliflozin is the first DPP-4i/SGLT-2i combination product to be approved in Europe.
 
Qtern is indicated for adults with type 2 diabetes aged 18 years and older to improve glycaemic control when metformin and/or sulphonylurea and one of the mono-components of Qtern alone do not provide adequate control, or when a patient is already being treated with the free combination of saxagliptin and dapagliflozin. 
 
Elisabeth Björk, Vice President, Head of Cardiovascular and Metabolic Diseases, Global Medicines Development at AstraZeneca said: “Nearly half of all people with type 2 diabetes are unable to reach their treatment goal and so risk developing complications due to hyperglycaemia. Qtern is the first combination product of its kind approved in Europe and an important new treatment option to help patients reach their goals through powerful HbA1c reduction.”
 
The approval is based on data from three trials in type 2 diabetes submitted to the European Medicines Agency. In two trials, the combination of saxagliptin and dapagliflozin with metformin resulted in statistically significant reductions in HbA1c in comparison to patients treated with placebo. An additional trial showed that the combination of saxagliptin and dapagliflozin added to metformin resulted in statistically superior reductions in HbA1c in comparison to patients treated with saxagliptin or dapagliflozin alone added to metformin. In these trials, the safety profile of Qtern was similar to the known safety profiles of saxagliptin and dapagliflozin.
 
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. Our current portfolio consists of the three newest classes of non-insulin, anti-diabetic treatments that support individualised treatment approaches: SGLT-2 inhibitors, GLP-1 receptor agonists and DPP-4 inhibitors.
 
As a main 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 therapy areas - Respiratory and Autoimmunity, Cardiovascular and Metabolic Diseases, and Oncology. The Company is also active in inflammation, infection and neuroscience through numerous collaborations. 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    
 
CONTACTS
 
Media Enquiries
 
 
 
Neil Burrows
 
UK/Global
 
+44 203 749 5637
 
Vanessa Rhodes
 
UK/Global
 
+44 203 749 5736
 
Karen Birmingham
 
UK/Global
 
+44 203 749 5634
 
Rob Skelding
 
UK/Global
 
+44 203 749 5821
 
Jacob Lund
 
Sweden
 
+46 8 553 260 20
 
Michele Meixell
 
US
 
+1 302 885 2677
 
Investor Relations
 
 
UK
 
 
Thomas Kudsk Larsen
 
 
+44 203 749 5712
 
Craig Marks
 
Finance, Fixed Income, M&A
 
+44 7881 615 764
 
Nick Stone
 
Respiratory & Autoimmunity
 
+44 203 749 5716
 
Henry Wheeler
 
Oncology
 
+44 203 749 5797
 
Christer Gruvris
Infection & Neuroscience
+44 203 749 5711
US
 
 
Lindsey Trickett
 
Cardiovascular & Metabolic Diseases
 
+1 240 543 7970
 
Mitchell Chan
 
 Oncology
 
+1 240 477 3771
 
Toll-free
 
+1 866 381 7277
 
Adrian Kemp
Company Secretary
AstraZeneca PLC
 
-ENDS-
 
 
 
 
 
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
 
 
 
Date: 19 July 2016
 
 By:  /s/ Adrian Kemp
Name: Adrian Kemp
Title: Company Secretary
 
 
 
 

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