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.