AstraZeneca
(NYSE:AZN) and Bristol-Myers
Squibb (NYSE:BMY) today announced that the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency (EMA) has
adopted a positive opinion recommending approval of Xigduo™ (dapagliflozin
and metformin hydrochloride) for adults aged 18 and older with type 2
diabetes mellitus as an adjunct to diet and exercise to improve
glycaemic control in patients inadequately controlled on their current
metformin-based treatment regimen or who are currently being treated
with the combination of dapagliflozin and metformin as separate tablets.
Xigduo™ combines dapagliflozin (tradename Forxiga®),
a selective and reversible inhibitor of sodium-glucose cotransporter 2
(SGLT2), and metformin hydrochloride in a twice daily tablet. This is
the first CHMP recommendation for a SGLT2 and metformin hydrochloride
fixed dosage combination. The CHMP's positive opinion will now be
reviewed by the European Commission, which has the authority to approve
medicines for the European Union. The final decision will be applicable
to all 28 European Union member countries plus Iceland and Norway.
Xigduo™ combines Forxiga and metformin
hydrochloride, two anti-hyperglycaemic products with complementary
mechanisms of action to improve glycaemic control. Forxiga, the
first medicine in the SGLT2 class to gain regulatory approval, is
currently approved for the treatment of type 2 diabetes in the European
Union, Argentina, Australia, Brazil, Iceland, Mexico, Norway and New
Zealand.
About SGLT2 Inhibition
The kidney plays an important role in maintaining normal glucose balance
by filtering and reabsorbing glucose from circulation. SGLT2, a
sodium-glucose cotransporter found predominantly in the kidney, is
responsible for the majority of glucose reabsorption. In patients with
type 2 diabetes, the capacity of the kidney to reabsorb glucose is
increased by approximately 20%, further exacerbating the hyperglycemia
associated with the disease. Selective inhibition of SGLT2 reduces the
reabsorption of excess glucose and enables its removal via the urine.
About Diabetes
In 2013, diabetes was estimated to affect more than 380 million people
worldwide. The prevalence of diabetes is projected to reach more than
592 million by 2035. Type 2 diabetes accounts for approximately 90% to
95% of all cases of diagnosed diabetes in adults. Type 2 diabetes is a
chronic disease characterized by insulin resistance and dysfunction of
beta cells in the pancreas, leading to elevated glucose levels. Over
time, this sustained hyperglycemia contributes to further progression of
the disease. Significant unmet needs still exist, as many patients
remain inadequately controlled on their current glucose-lowering regimen.
AstraZeneca/Bristol-Myers Squibb Diabetes Alliance
Dedicated to addressing the global burden of diabetes by advancing
individualized patient care, AstraZeneca and Bristol-Myers Squibb are
working in collaboration to research, develop and commercialize a
versatile portfolio of innovative treatment options for diabetes and
related metabolic disorders that aim to provide treatment effects beyond
glucose control. Find out more about the Alliance and our commitment to
meeting the needs of health care professionals and people with diabetes
at www.astrazeneca.com
or www.bms.com.
About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business
that focuses on the discovery, development and commercialization of
prescription medicines, primarily for the treatment of cardiovascular,
metabolic, respiratory, inflammation, autoimmune, oncology, infection
and neuroscience diseases. 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.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission
is to discover, develop and deliver innovative medicines that help
patients prevail over serious diseases. For more information about
Bristol-Myers Squibb, visit www.bms.com
or follow us on Twitter at http://twitter.com/bmsnews.
![](http://cts.businesswire.com/ct/CT?id=bwnews&sty=20131122005401r1&sid=ntxv4&distro=nx)
Copyright Business Wire 2013