FORXIGA (dapagliflozin) receives positive CHMP opinion in the European Union for the treatment of type 2 diabetes

[Editor's Note: As of early May, 2012, the FDA has not made an announcement of its decision about dapagliflozin. See FDA Advisory Committee makes recommendation on investigational compound dapagliflozin]

Friday, 20 April 2012

AstraZeneca and Bristol-Myers Squibb Company today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of FORXIGA (dapagliflozin) tablets for the treatment of type 2 diabetes, as an adjunct to diet and exercise, in combination with other glucose-lowering medicinal products including insulin, and as a monotherapy in metformin intolerant patients.

Dapagliflozin is an investigational selective and reversible inhibitor of sodium-glucose co-transporter 2 (SGLT2), which works independently of insulin. This is the first in the new SGLT2 class to receive a positive CHMP opinion for the treatment of type 2 diabetes, a disease where high unmet medical need exists.

The positive opinion was reached after the CHMP reviewed data from a comprehensive clinical development programme that included 11 core Phase III trials assessing the safety and efficacy of dapagliflozin as a once-daily oral therapy. These trials involved 5,693 patients with type 2 diabetes, including 3,939 patients treated with dapagliflozin.

Dapagliflozin 10mg is intended as a once-daily oral dose in adult patients with type 2 diabetes to improve glycaemic control:

• As a monotherapy, when diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to intolerance;
• In combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.

David Brennan, Chief Executive Officer, AstraZeneca, said: “We are pleased the CHMP has given a positive assessment of the benefit/risk profile of this novel product in a new class for the treatment of type 2 diabetes, an area of high unmet medical need.”

The CHMP's positive opinion on dapagliflozin will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union.

NOTES TO EDITORS

About SGLT2 Inhibition

The kidney plays an important role in glucose balance, normally filtering ~180g of glucose each day, with virtually all glucose being reabsorbed back into circulation. SGLT2 is a major sodium-glucose co-transporter in the kidney and is an insulin-independent pathway for the re-absorption of glucose back into the blood. Selective inhibition of SGLT2 facilitates the excretion of glucose and associated calories in the urine, thereby lowering blood glucose levels.

About Type 2 Diabetes

At the end of 2011, diabetes was estimated to have affected nearly 53 million people aged 20-79 in Europe, and this figure is projected to rise to more than 64 million by 2030. Type 2 diabetes accounts for approximately 85 to 95% of all cases of diagnosed diabetes in adults. Type 2 diabetes is a chronic disease characterised by insulin resistance and/or dysfunction of beta cells in the pancreas, which decreases insulin sensitivity and secretion, leading to elevated blood glucose levels. Over time, this sustained hyperglycaemia contributes to worsening insulin resistance and further beta cell dysfunction. Significant unmet need exists as many patients remain uncontrolled on their current glucose-lowering regimen.

Bristol-Myers Squibb and AstraZeneca Collaboration

Bristol-Myers Squibb and AstraZeneca entered into a collaboration in January 2007 to enable the companies to research, develop and commercialise select investigational drugs for type 2 diabetes. The Bristol-Myers Squibb/AstraZeneca Diabetes collaboration is dedicated to global patient care, improving patient outcomes and creating a new vision for the treatment of type 2 diabetes.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease. 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.

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