The fixed-dose combination of saxagliptin and dapagliflozi is intended for the treatment of adult patients with Type 2 diabetes.
The CRL said more clinical data is required to support NDA.
AstraZeneca plans to work closely with the FDA to resolve the appropriate next steps for the NDA and is committed to the development of the saxagliptin/dapagliflozin fixed-dose combination.
AstraZeneca has the goal of developing life-changing medicines that aim to reduce the global burden and complications of diabetes. Its current portfolio consists of the three newest classes of non-insulin, anti-diabetic treatments that support individualized treatment approaches: SGLT-2 inhibitors, GLP-1 receptor agonists and DPP-4 inhibitors.
Diabetes affects approximately 29.1 million people in the United States and more than 387 million people worldwide. Type 2 diabetes accounts for approximately 90-95 percent of all diagnosed cases in the United States.
Type 2 diabetes is a chronic disease characterized by multiple pathophysiologic defects leading to elevated glucose levels. Many patients remain inadequately controlled on their current glucose-lowering regimen.
AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.
Alerts Sign-up