AstraZeneca has announced that the US Food and Drug Administration (FDA) has issued a complete response letter regarding the supplemental New Drug Application for Farxiga (dapagliflozin), meaning that the governing body has initially rejected the treatment.
The application was as an adjunct treatment to insulin to improve glycaemic control in adult patients with type I diabetes, when insulin alone does not provide adequate glycaemic control.
The news comes hot on the heels of data from the Phase III DECLARE-TIMI 58 trial, which found that the drug showed a 47% reduction in the composite of kidney function decline, end-stage renal disease (ESRD) or renal death.
Elisabeth Björk, senior vice president, BioPharmaceuticals R&D, said of the data: “Heart failure and renal diseases are two of the most common and early complications experienced by people living with type II diabetes, and are too often overlooked. They contribute to a growing economic burden on the global healthcare system and can lead to fatal outcomes for patients. These data continue to offer clinically relevant evidence of the early cardio-renal effects of Farxiga.”
Farxiga is an inhibitor of SGLT2 indicated as additional treatment to diet and exercise to improve glycaemic control in adults with type II diabetes. It is not approved to reduce the risk of renal or CV death, or to slow the progression of kidney disease.
AstraZeneca has said that it will work closely with the FDA to discuss the next steps.