AstraZeneca and Bristol-Myers Squibb receive complete response letter from US FDA for dapagliflozin

AstraZeneca and Bristol-Myers Squibb Company today announced that the US Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for investigational compound dapagliflozin for the treatment of type 2 diabetes in adults.

The complete response letter requests additional clinical data to allow a better assessment of the benefit-risk profile for dapagliflozin. This includes clinical trial data from ongoing studies and may require information from new clinical trials. AstraZeneca and Bristol-Myers Squibb will work closely with the FDA to determine the appropriate next steps for the dapagliflozin application and are in ongoing discussions with health authorities in Europe and other countries as part of the application procedures.

AstraZeneca and Bristol-Myers Squibb remain committed to dapagliflozin and its development. This commitment is based on the benefit-risk profile of this investigational medicine, from a clinical development programme that included more than 8,000 adult patients with type 2 diabetes (with more than 5,000 patients treated with dapagliflozin) in 19 clinical trials.