AstraZeneca today announced that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for the investigational fixed-dose combination of saxagliptin and dapagliflozin for the treatment of adult patients with type 2 diabetes.
The CRL states that more clinical data are required to support the application. This includes clinical trial data from ongoing or completed studies and may require information from new studies.
AstraZeneca will work closely with the FDA to determine the appropriate next steps for the NDA and remains committed to the development of the saxagliptin/ dapagliflozin fixed-dose combination.
This announcement does not affect ongoing interactions with other health authorities as part of these individual application procedures. Based on the information available, the CRL is not expected to affect individual components of saxagliptin or dapagliflozin, which are approved for the treatment of adult patients with type 2 diabetes.