Fast Track Designation for Dapagliflozin by FDA

      FDA’s Fast Track program is intended to accelerate the development and review of new medicines for the treatment of serious conditions where there is an unmet treatment need. Forxiga (Dapagliflozin) is a drug used to improve glycemic control in adults with type 2 diabetes both as monotherapy or in combinations. In August, the FDA granted Fast Track designation for dapagliflozin to reduce the risk of cardiovascular death, or the worsening of heart failure in adults with heart failure with reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF). The grant was based on the Phase III trials, DAPA-HF and DELIVER.

      Forxiga was found effective in reducing the death and hospitalization in patients who have HFrEF with and without diabetes by 26 percent. The breakthrough results of the DAPA-HF trial were presented in a Hot Line Session at the European Society of Cardiology (ESC) in August 2019.