Farxiga Granted FDA Fast Track Designation for Heart Failure Following Acute Myocardial Infarction

Compiled by S. Li

AstraZeneca Announces FDA Fast Track Designation for Farxiga (dapagliflozin) to Reduce Risk of Heart Failure Hospitalization or Cardiovascular Death in Adult Patients Following Acute Myocardial Infarction

This approval is based on the Phase 3 clinical trial named DAPA-MI, which investigated the safety and efficacy of Farxiga in a specified patient population. In addition to Farxiga receiving Fast Track designation, the DAPA-MI clinical trial was also granted Special Protocol Assessment (SPA) status. SPA is a high-level designation rarely granted by the FDA, signifying that the design of the Phase 3 clinical trial is well aligned with future market application.

The DAPA-MI trial aims to evaluate the efficacy and safety of Farxiga in reducing the risk of hospitalization for heart failure (hHF) and cardiovascular (CV) events in adult patients without type 2 diabetes following acute myocardial infarction. The study plans to enroll 6,400 patients from Sweden and the United Kingdom, with recruitment expected to begin in the fourth quarter of this year.

The DAPA-MI trial integrated the enrollment requirements of a placebo-controlled, randomized clinical trial with routine care, thereby facilitating the approval of new indications. In this study, patients and their attending physicians jointly participated in data registration, integrating the trial process into daily clinical practice. Unlike traditional clinical studies, patients were not required to travel to designated clinical trial centers.

Mene Pangalos, Executive Vice President of BioPharmaceuticals R&D at AstraZeneca, stated that DAPA-MI is the first randomized controlled trial seeking registration based on indication, which will shorten data access time, save recruitment time and costs, while minimizing the burden on patients and investigators. The FDA’s decision acknowledges the importance of this trial and recognizes the potential of Farxiga in patients with heart disease complicated by secondary heart failure.

Acute Myocardial Infarction, also known as a heart attack, is a common and serious condition and one of the causes of heart failure. Approximately 7 million people worldwide suffer from heart attacks each year. Over the years, the standard of care for patients with acute myocardial infarction has improved significantly, but patient outcomes have not shown substantial improvement. Therefore, new interventions are needed to reduce cardiovascular risk in these patients.

Farxiga is a first-in-class, once-daily oral selective sodium-glucose cotransporter 2 (SGLT2) inhibitor that acts independently of insulin by selectively inhibiting SGLT2 in the kidneys, thereby helping patients excrete excess glucose through urine. In addition to its glucose-lowering effects, the drug offers additional benefits such as weight loss and blood pressure reduction. In China, dapagliflozin was approved in March 2017 as a monotherapy to improve glycemic control in adult patients with type 2 diabetes.

In May 2020, Farxiga was approved in the United States to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with heart failure with reduced ejection fraction (HFrEF), with or without type 2 diabetes. Farxiga is also indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. In addition to DAPA-MI, the Phase III DAPA-CKD clinical trial of Farxiga, which aimed to evaluate its effects in patients with chronic kidney disease (CKD), was ongoing; however, the trial was terminated early by the Data Monitoring Committee due to overwhelming therapeutic benefit.

Reference Source: Farxiga Granted Fast Track Designation in the US for Heart Failure Following Acute Myocardial Infarction, Leveraging an Innovative Registry-Based Trial Design