AstraZeneca PLC Wins FDA Approval For Two-In-One Diabetes Pill

Published: Oct 31, 2014

AstraZeneca Wins FDA Approval For Two-In-One Diabetes Pill

October 30, 2014

By Krystle Vermes, BioSpace.com Breaking News Staff

AstraZeneca announced today that the U.S. Food and Drug Administration has approved Xigduo XR, also known as dapagliflozin and metformin hydrochloride, for the treatment of type 2 diabetes in adults. The once-daily tablet comes with two anti-hyperglycemic agents with complementary mechanism of action.

Dapagliflozin is an inhibitor of sodium-glucose cotransporter 2, while metformin hydrochloride is a biguanide. SGLT2 inhibitors are a new type of medicine that removes glucose from the body through the kidneys.

“The addition of Xigduo XR to our U.S. diabetes portfolio is further evidence of AstraZeneca’s commitment to develop new treatment options for patients with type 2 diabetes,” said Elisabeth Björk, head of cardiovascular and metabolism in global medicines development at AstraZeneca. “The approval of once-daily XIGDUO XR provides prescribers and adult patients with another treatment choice, supporting a more personalized approach to disease management.”

Xigduo XR is the first medicine to combine an SGLT2 inhibitor and metformin in a single pill and receive approval in the U.S. It is an adjunct therapy in addition to diet and exercise in patients with type 2 diabetes. However, it is not recommended for patients with type 1 diabetes or diabetic ketoacidosis. Currently, the drug is already approved in Australia for patients with type 2 diabetes.

New Screening for Type 2 Diabetes
In the beginning of October, the American Diabetes Association recognized the U.S. Preventative Services Task Force for its efforts to detect type 2 diabetes by elevating the draft recommendation for screenings. Its draft included multiple risk-factor based type 2 diabetes screening for asymptomatic patients in addition to screening people with high blood pressure.

“The American Diabetes Association is thrilled with the decision of the U.S. Preventive Services Task Force to strengthen their recommendation and take into consideration the wealth of research pointing to the need for risk-factor based screening in type 2 diabetes,” said Robert Ratner, chief scientific and medical officer of the American Diabetes Association. “Early diagnosis of both type 2 and prediabetes is essential in improving the outcomes for these patients. Undeniable data show the efficacy and cost effectiveness of preventing diabetes.”

Today, approximately 8 million children and adults in the U.S. are living with diabetes, but have not been diagnosed with the disease. The estimated economic cost of undiagnosed instances is around $18 billion each year, highlighting the need for better screening and detection methods.

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