Xigduo™ (dapagliflozin and metformin hydrochloride) Receives Positive CHMP
Opinion in the European Union for the Treatment of Type 2 Diabetes
LONDON & PRINCETON, N.J. -- November 22, 2013
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
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.
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.
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.
Carmel Hogan, 33-1588-38295
Ken Dominski, 609-252-5251
Donna Huang, 302-885-6396
Karl Hard, 44-20-7604-8123
Ranya Dajani, 609-252-5330
Ryan Asay, 609-252-5020
Press spacebar to pause and continue. Press esc to stop.