AstraZeneca announced that Farxiga (dapagliflozin) received fast track designation from the US Food and Drug Administration (FDA). The indication for which the drug received the designation is to reduce the risk of cardiovascular death or worsening of heart failure, adults with heart failure with reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF).
Fast track designation was provided based on the Phase III trials, DAPA-HF and DELIVER. The drug is investigated in patients with heart failure with reduced ejection fraction (HFrEF) and preserved ejection fraction (HFpEF) respectively.
Fast track designation is given for medicines which are indicated to treat severe conditions, where there is an unmet need.
Farxiga is currently indicated as monotherapy or in combination for glycemic control in patients with type-2 diabetes mellitus in adults.