Farxiga, who treats heart failure after the death of acute myocardial infarction, is fda fast-track.

AstraZeneca recently announced that Farxiga (dapagliflozin, Dagrenet) has been granted fast-track status by the FDA to reduce the risk of hospitalization (hHF) or cardiovascular (CV) death in adult patients due to acute myocardial infarction (MI) or heart attack.
award edited based on a Phase III clinical trial called DAPA-MI that explored the safety and effectiveness of Farxiga in a designated patient population.
In addition to Farxiga's fast-track eligibility, DAPA-MI was awarded the Special Experimental Program Assessment (SPA) status.
SPA is a high-level statement rarely granted by the FDA, and its significance is to show that the design of the Phase III clinical trial is well aligned with future market applications.
DAPA-MI, which aims to assess the efficacy and safety of Farxiga in reducing the risk of hHF and CV disease after death from acute myocardial infarction in adult patients without type 2 diabetes, plans to recruit 6,400 patients from Sweden and the United Kingdom and is expected to begin recruiting in the fourth quarter of this year.
DAPA-MI trials integrate signed registration requirements for routine care with placebo-controlled randomized clinical trials, which is more conducive to approval of new indications.
in the study, patients and their attending physicians participate in information registration and integrate the trial process into daily clinical practice.
different from traditional clinical studies, patients do not need to go to a designated clinical trial center in a trial. Mene Pangalos, executive vice president of biopharmaceutical research and development at
AstraZeneca, said DAPA-MI is the first randomized controlled trial to seek registration based on indications, which will reduce data access time, save recruitment time and costs, and minimize the burden on patients and researchers.
FDA decision recognizes the importance of the trial and insights into Farxiga's potential in patients with heart disease combined secondary heart failure.
acute myocardial infarction, also known as heart attack, is a common and serious disease and one of the causes of heart failure.
about 7 million heart attack patients worldwide each year.
the standard of care for patients with acute myocardial infarction has improved significantly over the
years, but the patient's prognosis has not significantly improved, so new interventions are needed to reduce the cardiovascular risk of these patients.
Farxiga is a pioneering, once-daily oral, selective sodium-glucose co-transporter (SGLT2) inhibitor that acts independently of insulin and selectively inhibits SGLT2 in the kidneys, helping patients to excrete excess glucose from the urine.
in addition to the sugar-lowering effect, the drug also has the added benefits of losing weight and lowering blood pressure.
in China, dapagliflozin was approved in March 2017 as a single drug for improving blood sugar control in adult sepsis patients with type 2 diabetes.
May 2020, Farxiga was approved in the United States to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with or without type 2 diabetes.
, Farxiga is also a diet-assisted diet and exercise drug used to improve blood sugar control in adults with type 2 diabetes.
In addition to DAPA-MI, Farxiga has a Phase III clinical trial of DAPA-CKD, which is being conducted to assess its effects in patients with chronic kidney disease (CKD), but has been called off in advance by the Data Monitoring Board based on overwhelming therapeutic advantages.
reference source: Farxiga Granted Fast Track Saar in the US for heart failure smh myocardial indydd yn diedding an innovative-rhey-trial design.