Qternmet XR approved in the US for type-2 diabetes

RNS Number : 9632X
AstraZeneca PLC
03 May 2019
 

3 May 2019 07:00 BST

 

 Qternmet XR approved in the US for the treatment of type-2 diabetes

 

The US Food and Drug Administration (FDA) has approved Qternmet XR (dapagliflozin, saxagliptin and metformin hydrochloride) extended release tablets as an oral adjunct treatment to diet and exercise to improve glycaemic control in adults with type-2 diabetes (T2D).

 

The approval is based on two Phase III trials, which evaluated combinations of dapagliflozin and saxagliptin on a background of metformin over 24 weeks, in patients with inadequately-controlled T2D.

 

In one trial, treatment with 5mg dapagliflozin/5mg saxagliptin in addition to metformin demonstrated statistically-significant decreases in HbA1c (average blood glucose levels), and an increase in the number of patients achieving the recommended HbA1c treatment goal of <7%. In the second trial, treatment with 10mg dapagliflozin/5mg saxagliptin in addition to metformin extended release demonstrated statistically-significant decreases in HbA1c, and an increase in the number of patients achieving an HbA1c <7%.

 

The safety results of the individual medicines in these trials were consistent with their known profile.

 

About Qternmet XR

Qternmet XR is a once-daily, oral medicine compromised of the selective sodium‑glucose cotransporter-2 (SGLT-2) inhibitor dapagliflozin, the dipeptidyl peptidase‑4 (DPP‑4) inhibitor saxagliptin and metformin hydrochloride extended release. Qternmet XR is approved in the US as an adjunct to diet and exercise to improve glycaemic control in adults with type-2 diabetes.

 

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.

 

 

Media Relations

 

 

Gonzalo Viña

 

+44 203 749 5916

Rob Skelding

Oncology

+44 203 749 5821

Rebecca Einhorn

Oncology

+1 301 518 4122

Matt Kent

BioPharma

+44 203 749 5906

Jennifer Hursit

Other

+44 203 749 5762

Christina Malmberg Hägerstrand

Sweden

+46 8 552 53 106

Michele Meixell

US

+1 302 885 2677

 

 

 

Investor Relations

 

 

Thomas Kudsk Larsen

 

+44 203 749 5712

Henry Wheeler

Oncology

+44 203 749 5797

Christer Gruvris

BioPharma (cardiovascular; metabolism)

+44 203 749 5711

Nick Stone

BioPharma (respiratory; renal)

+44 203 749 5716

Josie Afolabi

Other medicines

+44 203 749 5631

Craig Marks

Finance, fixed income

+44 7881 615 764

Jennifer Kretzmann

Corporate access, retail investors

+44 203 749 5824

US toll-free

 

+1 866 381 72 77

 

Adrian Kemp

Company Secretary

AstraZeneca PLC


This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com.
 
END
 
 
MSCLLLLBKEFEBBX

Companies

AstraZeneca (AZN)
UK 100