Farxiga : AstraZeneca gets FDA fast track status for heart failure after MI

AstraZeneca has secured fast track designation for Farxiga (dapagliflozin) in the US for its use in reducing the risk of hospitalization for heart failure (hHF) or cardiovascular (CV) death in adults after an acute myocardial infarction (MI) or heart attack.

The fast track designation for the oral once-daily sodium-glucose co-transporter-2 (SGLT2) inhibitor is based on the phase 3 DAPA-MI clinical trial that will study the efficacy and safety of Farxiga in the patient population.

The DAPA-MI clinical trial is held in collaboration with Uppsala Clinical Research Center (UCR) and Myocardial Ischaemia National Audit Project (MINAP) across the UK. It will evaluate the benefit of Farxiga in patients without type-2 diabetes (T2D) following a heart attack. The late-stage clinical trial is likely to start patient enrollment in the fourth quarter of this year.

Mene Pangalos – AstraZeneca BioPharmaceuticals R&D Executive Vice President 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.

“Today’s 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.”

AstraZeneca gets FDA fast track status for Farxiga for heart failure after heart attack. Photo courtesy of AstraZeneca.

Around a couple of months ago, Farxiga bagged FDA approval for cutting down 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.

The SGLT2 inhibitor is also approved by the FDA as an adjunct to diet and exercise to boost glycaemic control in adults with type-2 diabetes. Apart from that, Farxiga is being studied for its use in patients with chronic kidney disease (CKD) in the phase 3 DAPA-CKD clinical trial, which was halted early after it was found to have overwhelming efficacy as per a data monitoring committee determination.