In the Phase III DAPA-HF trial, Farxiga has reduced the incidence of the composite outcome of CV death or the worsening of HF, compared to placebo
US FDA accepts AstraZeneca’s sNDA and grants priority review for Farxiga (Courtesy: AstraZeneca.)
AstraZeneca has received the US Food and Drug Administration (FDA) acceptance for its supplemental New Drug Application (sNDA), and was granted Priority Review for its Farxiga (dapagliflozin).
Farxiga is an oral, selective inhibitor of human sodium-glucose co-transporter 2 (SGLT2), which improves glycaemic control, while balancing weight and blood-pressure, in addition to diet and exercise, in adults with type-2 diabetes (T2D).
The regulatory authority has certified Farxiga to reduce the risk of cardiovascular (CV) death or deteriorating heart failure (HF) in adults with heart failure with reduced ejection fraction (HFrEF), with and without (T2D).
AstraZeneca biopharmaceuticals’ R&D executive vice-president, Mene Pangalos, said: “Farxiga is well established in the treatment of type-2 diabetes and this Priority Review shows its potential to also impact millions of patients with heart failure. If approved, Farxiga will be the first and only medicine of its kind indicated to treat patients with heart failure.”
FDA will take a decision on AstraZeneca’s sNDA in the second quarter of 2020
The company said that its sNDA was supported by positive results from the Phase III DAPA-HF trial, which demonstrated that Farxiga has reduced the incidence of the composite outcome of CV death or the worsening of HF, when compared to a placebo.
Under the Prescription Drug User Fee Act, the regulatory body is expected to take a decision on the supplemental application in the second quarter of 2020.
The FDA granted Fast Track designation for the development of Farxiga to inhibit the progression of renal failure, and for preventing CV and renal death in patients with chronic kidney disease, with and without T2D in August 2019 and and granted the same the following month for its development in HF.
October 2019 saw the FDA approving Farxiga’s capability in reducing the risk of hospitalisation due to heart failure in patients with T2D and established cardiovascular disease, or multiple CV risk factors.
Global biopharmaceutical company AstraZeneca is engaged in the discovery, development and commercialisation of prescription medicines for the treatment of oncological, cardiovascular, renal and metabolism, and respiratory diseases.