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news.AstraZeneca has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) for the investigational fixed-dose combination of saxagliptin and dapagliflozin to treat adult patients with type 2 diabetes.
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The CRL states that additional clinical information is required to support the company’s new drug application (NDA).
It includes clinical trial data from ongoing or completed studies and could require information from new studies.
AstraZeneca said it will work with the FDA to identify the next steps for the NDA. The company noted that it remains committed towards the development of the saxagliptin/ dapagliflozin fixed-dose combination.
It is projected that diabetes affects 29.1 million people in the US and over 387 million people globally.
According to estimates, the prevalence of diabetes is estimated to reach more than 592 million people globally by 2035 and type 2 diabetes accounts for about 90% to 95% of all diagnosed cases in the US.
Type 2 diabetes is a chronic and progressive disease characterized by various pathophysiologic defects, resulting in elevated glucose levels.
AstraZeneca is developing medicines that intend to reduce the global burden and complications of diabetes.
The company’s current portfolio features three new classes of non-insulin, anti-diabetic treatments that support individualized treatment approaches. They include SGLT-2 inhibitors, GLP-1 receptor agonists and DPP-4 inhibitors.