AZ' Farxiga fast-tracked for heart failure following MI
AstraZeneca's Farxiga (dapagliflozin) has been granted a Fast Track Designation in the US for reducing the risk of hospitalisation for heart failure (hHF) or cardiovascular (CV) death in adults following an acute myocardial infarction (MI) or heart attack.
The move, which could accelerate the drug's development in this setting, is based on the Phase III DAPA-MI trial, which will explore the efficacy and safety of Farxiga in this patient population.
The trial integrates routine care and registries with the requirements of a rigorous placebo-controlled, randomised clinical trial, 'thus aiming for an approvable label indication', AZ said.
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', AZ noted in a press release.
The FDA has already granted a Special Protocol Assessment (SPA) agreement for the trial, which is essentially a declaration by the FDA that the trial's design is acceptable for a future marketing application.
“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,” said Mene Pangalos, executive vice president, BioPharmaceuticals R&D.
The FDA's decision has “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 is conducted in collaboration with Uppsala Clinical Research Center (UCR) and Myocardial Ischaemia National Audit Project (MINAP) in the UK. It will explore the benefit of Farxiga in patients without type 2 diabetes following an acute MI, and is expected to begin recruiting in the fourth quarter of 2020.
Farxiga is approved in the US to reduce the risk of CV death and hHF in adults with HF (NYHA class II-IV) with reduced ejection fraction (HFrEF) with and without type 2 diabetes, and as an adjunct to diet and exercise to improve glycaemic control in adults with the condition.
The drug is also being evaluated for patients with chronic kidney disease (CKD) in the Phase III DAPA-CKD trial, which was stopped early after a Data Monitoring Committee determination of overwhelming efficacy.
17th July 2020