EU approves Forxiga for treatment of type 2 diabetes

Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) today announced that the European Commission has approved Forxiga (dapagliflozin) tablets for the treatment of type 2 diabetes in the European Union (EU). Forxiga is a selective and reversible inhibitor of sodium-glucose cotransporter 2 (SGLT2) that works independently of insulin to help remove excess glucose from the body, a unique mode of action not seen in any other currently available treatments for type 2 diabetes. This is the first medicine in the new SGLT2 class to gain regulatory approval for the treatment of type 2 diabetes, a disease in which high unmet medical need exists.

“The approval of Forxiga represents a significant advance in the treatment of type 2 diabetes.”

Forxiga tablets are indicated as a once-daily oral medication to improve glycaemic control in adult patients with type 2 diabetes. Forxiga is intended to be used as an adjunct to diet and exercise in combination with other glucose-lowering medicinal products, including insulin, or as a monotherapy in metformin-intolerant patients.

"Many Europeans with type 2 diabetes are not reaching treatment goals, increasing their risk of developing complications, so there is a critical need for new treatments. Forxiga provides physicians with a completely new option to help improve glycaemic control that complements commonly used glucose-lowering treatments like metformin and insulin with additional benefits of weight loss and blood pressure lowering," said John Wilding, DM, FRCP, Professor of Medicine and Honorary Consultant Physician, Head of Diabetes and Endocrinology Clinical Research Unit, University Hospital Aintree (UK). "The approval of Forxiga represents a significant advance in the treatment of type 2 diabetes."

Forxiga (dapagliflozin) works in the kidney to selectively inhibit SGLT2, resulting in the removal of excess glucose and its associated calories in the urine. Through the removal of excess glucose, Forxiga helps to reduce blood sugar levels. In clinical studies, Forxiga also showed reductions in weight and blood pressure. Bristol-Myers Squibb and AstraZeneca are currently seeking regulatory approval for Forxiga in several other countries.

"Diabetes is a progressive disease that requires a combination of treatment approaches over time," said Lamberto Andreotti, chief executive officer, Bristol-Myers Squibb. "Forxiga is the first of a new class of type 2 diabetes medication that works independently of insulin and represents a new treatment option for patients and physicians across Europe."

"We are excited about the approval of Forxiga in Europe, and the significant advancement it represents for the many millions of European patients with type 2 diabetes who need new options to manage this progressive disease," said Pascal Soriot, chief executive officer, AstraZeneca. "Forxiga is an important addition to the growing range of Bristol-Myers Squibb and AstraZeneca diabetes treatments and further demonstrates our commitment to addressing the unmet needs of adults with type 2 diabetes."


Bristol-Myers Squibb Company


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