By Fineline Cube UK pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN) has announced that it has received market approval from the National Medical Products Administration (NMPA) in China for its fixed dose combination of dapagliflozin and metformin, a treatment for type 2 diabetes. This once-daily compound is now the only sustained-release formulation in China that combines an SGLT-2 inhibitor with metformin. The drug is marketed globally by AstraZeneca under the trade name Xigduo XR.
Xigduo XR: A Unique Combination for Type 2 Diabetes Management
The approval of Xigduo XR marks a significant advancement in the treatment options for type 2 diabetes patients in China. As the only once-daily compound that combines the benefits of an SGLT-2 inhibitor with metformin in a sustained-release form, Xigduo XR offers a new approach to managing blood sugar levels effectively.
Clinical Evidence Supports Xigduo’s Efficacy and Safety
The approval of Xigduo is backed by robust clinical evidence from a bioequivalence study conducted in China and a global diabetes study. These studies demonstrated the efficacy and safety of the compound in treating type 2 diabetes patients, reinforcing its position as a valuable addition to the treatment arsenal.
Farxiga’s Broader Indications and Global Reach
AstraZeneca’s SGLT2 inhibitor, Farxiga (dapagliflozin), has previously been approved in China for the treatment of type 2 diabetes, heart failure with reduced ejection fraction, and chronic kidney disease. The global reach of Xigduo XR extends beyond China, with the product also registered in the US and Australia, highlighting AstraZeneca’s commitment to improving diabetes care worldwide.-Fineline Info & Tech