The European Commission has given AstraZaneca and Bristol-Myers Squibb’s type 2 diabetes treatment Xigduo marketing authorization across the European Union. Xigduo has been approved in 40 countries including the U.S.
Xigduo (dapagliflozin and metformin hydrochloride) is a SGLT2 inhibitor which selectively reduces reabsorption of excess glucose and helps remove it through the urine.
Astra Zeneca Vice President and Head of Late Phase Cardiovascular and Metabolic Development Elisabeth Björk said, “Xigduo is an important addition to the range of medicines to help patients manage glycemic control. We recognize that not all patients are alike and that different treatments are needed, supporting a more personalized approach to disease management… Metformin has long been a standard of diabetes care, and with the Xigduo approval, we now have an SGLT2 inhibitor and metformin combination product representing an innovative option for treating adults with type 2 diabetes.”
The drug has been approved in two doses for patients 18 and older with type 2 diabetes, particularly those who have been under metformin therapy alone or have received both drugs as monotherapies. Xigduo is intended to be an adjunct to proper diet and exercise.
Over 380 million people around the world are estimated to be affected by diabetes in 2013. Type 2 diabetes is responsible for approximately 85% to 95% of all diagnosed diabetes cases in adults. Type 2 diabetes is characterized by insulin resistance and beta cell dysfunction in the pancreas, ultimately leading to elevated blood sugar levels. Diabetes is expected to affect more than 592 million people by 2035.
Bristol-Myers Squibb Senior Vice President and Head of Development-Cardiovascular and Metabolics Fred Fiedorek said, “Type 2 diabetes is a growing global concern and a range of treatments are needed in order to appropriately manage this disease… The approval of Xigduo offers physicians another valuable treatment choice in the management of this progressive disease.”