The European Commission has approved Bristol-Myers Squibb and AstraZeneca’s new type 2 diabetes therapy, Forxiga (dapagliflozin), for use 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.
Forxiga tablets are indicated as a once-daily oral medication to improve glycemic 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.
Forxiga 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.