FDA Approves AstraZeneca's Xigduo For T2D

AstraZeneca announced that it has secured approval from the U.S. Food and Drug Administration (FDA) for its once-daily Xigduo XR for the treatment of adult patients with Type 2 diabetes.

Xigduo XR (dapagliflozin and metformin hydrochloride extended-release) is a once-daily oral combination tablet of an SGLT2 inhibitor and metformin HCl extended-release. The drug comprises two anti-hyperglycaemic agents with matching mechanisms of action. These agents are dapagliflozin, marketed as Farxiga, and metformin hydrochloride (HCl) extended-release, a biguanide. SGLT2 inhibitors, such as Farxiga, belong to an emerging class of drugs that remove glucose from the body through urine. Xigduo is indicated as an adjunct therapy to proper diet and exercise for patients with T2D and who are eligible for treatment with both dapagliflozin and metformin.

Elisabeth Björk, Head of Cardiovascular & Metabolism, Global Medicines Development at AstraZeneca, said, “The approval of once-daily XIGDUO XR provides prescribers and adult patients with another treatment choice, supporting a more personalized approach to disease management.”

The FDA approval was supported by positive results from four Phase 3 clinical trials which showed that the drug had comparable safety and efficacy as dapagliflozin and metformin XR separate tablets. Xigduo is already approved in Australia. Earlier this year, the company also received approval from the EU for Xigduo.

Diabetes continues to affect over 382 million people around the world including 29.1 million people in the U.S. Of these, Type 2 diabetes accounts for an estimated 90 to 95 percent of diagnosed diabetes cases in the U.S. The disease is expected to reach over 592 million people around the world by 2035.

Earlier this year, the British big pharma announced its complete acquisition of all drugs in Bristol-Myers Squibb’s diabetes business as part of their collaboration. This included Xigduo and Farxiga, among other drugs and treatments for diabetes. As a result of the transaction, AZ gained development, manufacturing, and marketing rights to the treatments as well as rights to two BMS manufacturing facilities.