AstraZeneca PLC POSITIVE CHMP OPINION IN EU FOR SAXA/DAPA (5635Z)
May 27 2016 - 7:36AM
UK Regulatory
TIDMAZN
RNS Number : 5635Z
AstraZeneca PLC
27 May 2016
POSITIVE CHMP OPINION IN EU FOR SAXA/DAPA (SAXAGLIPTIN AND
DAPAGLIFLOZIN) FOR ADULTS WITH TYPE-2 DIABETES
AstraZeneca today announced that the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency has
issued a positive opinion, recommending the approval of saxa/dapa
(saxagliptin and dapagliflozin) tablets for the treatment of adults
with type-2 diabetes. The fixed-dose combination of saxagliptin and
dapagliflozin has the potential to be the first DPP-4i/SGLT-2i
combination product approved in Europe.
Saxa/dapa is a fixed-dose combination of saxagliptin and
dapagliflozin being developed as a treatment for patients with
type-2 diabetes in adults aged 18 years and older. It is
recommended to be indicated as a treatment to improve glycaemic
control when metformin and/or sulphonylurea and one of the
mono-components of saxa/dapa alone do not provide adequate
glycaemic control, or when a patient is already being treated with
the free combination of saxagliptin and dapagliflozin.
The submission included data from three studies in type-2
diabetes. In two studies, the combination of dapagliflozin and
saxagliptin with metformin resulted in statistically significant
reductions in HbA1c in comparison to patients treated with placebo
that required additional control to existing saxagliptin and
metformin or dapagliflozin and metformin therapy. An additional
study showed that the combination of dapagliflozin and saxagliptin
added on to metformin resulted in statistically superior reductions
in HbA1c in comparison to patients treated with dapagliflozin or
saxagliptin alone added to metformin. In these trials, the safety
profile of saxa/dapa was similar to the known safety profiles of
saxagliptin and dapagliflozin.
The CHMP's positive opinion will now be reviewed by the European
Commission (EC), which has the authority to approve medicines for
the European Union (EU). The final decision by the EC is expected
in the coming months, and will be applicable to all 28 EU member
countries plus Iceland, Norway and Liechtenstein.
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 strategic 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 treatment 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, innovation-driven biopharmaceutical
business that focuses on the discovery, development and
commercialisation of prescription medicines, primarily for the
treatment of diseases in three main therapy areas - respiratory,
inflammation, autoimmune disease (RIA), cardiovascular and
metabolic disease (CVMD) and oncology - as well as in infection and
neuroscience. 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 7842 350541
Vanessa Rhodes UK/Global +44 7880 400690
Karen Birmingham UK/Global +44 7818 524012
+46 8 553 260
Jacob Lund Sweden 20
Michele Meixell US +1 302 885 2677
Investor Enquiries
UK
Thomas Kudsk Larsen +44 7818 524185
Nick Stone RIA, CVMD +44 7717 618834
Henry Wheeler Oncology +44 7788 354619
Craig Marks Finance +44 7881 615764
ING, Consensus
Christer Gruvris Forecasts +44 7827 836825
US
Lindsey Trickett CVMD, Oncology +1 240 543 7970
Mitch Chan Oncology +1 240 477 3771
Dial / Toll-Free +1 866 381 7277
Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD -
Cardiovascular and Metabolic Disease, ING - Infection, Neuroscience
and Gastrointestinal
27 May 2016
- ENDS -
This information is provided by RNS
The company news service from the London Stock Exchange
END
MSCBBGDUXXDBGLR
(END) Dow Jones Newswires
May 27, 2016 07:36 ET (11:36 GMT)
Astrazeneca (LSE:AZN)
Historical Stock Chart
From Mar 2024 to Apr 2024
Astrazeneca (LSE:AZN)
Historical Stock Chart
From Apr 2023 to Apr 2024