The FDA grants priority review for AZ’s Farxiga

Following the recent acceptance of a supplemental New Drug Application (sNDA), the US Food and Drug Administration (FDA) have granted priority review for AstraZeneca’s (AZ) Farxiga (dapagliflozin). The medication, which is being revised for the treatment in adults with reduced ejection fraction (HFrEF) regardless of having type two diabetes, to minimise the deterioration of heart failure or the danger of cardiovascular demise, is a first in the sodium glucose co-transporter 2 (SGLT2) class.

The judgement was based on data from the DAPA-HF phase 3 trial, published in ‘The New England Journal of Medicine’, showing that Farxiga and standard of care reduced the outcome of worsening heart failure and the risk of cardiovascular death compared to the given placebo.

Executive Vice President of BioPharmaceuticals R&D, Mene Pangalos, stated: “Farxiga is well established in the treatment of type two 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.”