AstraZeneca PLC FDA approves once-daily Qtern for type-2 diabetes (0243Y)
February 28 2017 - 2:02AM
UK Regulatory
TIDMAZN
RNS Number : 0243Y
AstraZeneca PLC
28 February 2017
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
This information is provided by RNS
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