The drug Farxiga has been granted Fast Track Designation in the US for evaluation in the treatment of heart failure.
AstraZeneca has been granted Fast Track Designation in the US for the development of Farxiga (dapagliflozin) to reduce the risk of hospitalisation for heart failure or cardiovascular death in adults following an acute myocardial infarction or heart attack.
The designation is based on the Phase III DAPA-MI trial that will explore the efficacy and safety of Farxiga in this patient population.
The Phase III DAPA-MI trial
The DAPA-MI trial will be integrating routine care and registries with the requirements of a rigorous placebo-controlled, randomised clinical trial, with an aim for an approvable label indication.
In DAPA-MI, patients and their treating physicians participating in registries can join the trial and integrate it within their routine clinical practice. Unlike conventional studies where patients often need to travel to a trial centre that may be far from home, this pragmatic, innovative approach delivers rigorous safety and efficacy data, while reducing patient burden and streamlining trial delivery.
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “The Phase III DAPA-MI trial is the first indication-seeking registry-based randomised controlled trial which will provide quicker access to data and reduce recruitment time and cost, while minimising patient and investigator burden.”
Adding that the, “FDA decision acknowledged the importance of this trial, which will provide valuable insights into Farxiga’s potential in patients who had a heart attack and went on to develop heart failure and also into how we can improve clinical trial design in the future.”
The DAPA-MI trial will be conducted in collaboration with Uppsala Clinical Research Center and Myocardial Ischaemia National Audit Project in the UK. It will explore the benefit of Farxiga in patients without Type 2 diabetes following an acute MI. It is expected to begin recruiting in the fourth quarter of 2020.