The Food and Drug Administration has issued a complete response letter to AstraZeneca regarding the supplemental New Drug Application (sNDA) for the use of dapagliflozin (Farxiga) as an adjunct treatment to insulin in patients with type 1 diabetes (T1D), when insulin alone does not provide adequate glycemic control.
In a press statement, the Company noted that it would work closely with the FDA to discuss next steps, however, did not mention the reasons why the FDA rejected the application. The sodium-glucose co-transporter 2 (SGLT2) inhibitor recently gained approval for T1D in Europe and Japan.
The sNDA contained data from the DEPICT (Dapagliflozin Evaluation in Patients with Inadequately Controlled Type-1 diabetes) clinical trial program which evaluated the safety and efficacy of dapagliflozin as an adjunct therapy to insulin in patients with inadequately controlled T1D. In both the DEPICT 1 (N=833) and DEPICT 2 (N=815) trials, treatment with dapagliflozin led to improvements in glycemic control, but was associated with more diabetic ketoacidosis events.
Farxiga is currently approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
For more information visit astrazeneca.com.