In Little-Used Process, FDA Grants Dapagliflozin Fast Track Status for Use After Heart Attack

It’s already been a banner year for AstraZeneca’s dapagliflozin (Farxiga), and on Thursday, the FDA offered more good news to the diabetes drug: it awarded a fast track designation for the drug to treat patients who have suffered a heart attack, based on a trial that’s been designed but hasn’t actually started yet.

Under a rarely used Special Protocol Assessment (SPA), the FDA granted the designation based on the “innovative” design of the forthcoming DAPA-MI trial, which will study patients who have experienced an acute myocardial infarction (MI). In a statement, AstraZeneca described the SPA as an advanced declaration that a phase 3 trial design “is acceptable for a future marketing application.”

The designation would be to reduce the risk of heart failure (HF) or cardiovascular death in patients who have suffered an acute MI, which is a known cause of HF.

Recruiting for DAPA-MI will start in collaboration with Uppsala Clinical Research Center and Minap in the United Kingdom in the fourth quarter of 2020. The trial will incorporate the use of registries with routine care along with the requirements of a randomized, placebo-controlled clinical trial. The use of registries to collect data from patients will reduce the need for patient travel and streamline data collection, at a time when many clinical trials are reporting difficulty enrolling patients due to COVID-19.

Other milestones in 2020. In May, dapagliflozin became the first drug originally developed for T2D to win approval to treat HF, whether or not patients have diabetes, based on results of the DAPA-HF trial. The study found the sodium glucose co-transporter 2 inhibitor reduced the risk of cardiovascular death or worsening of HF by 26% for patients with HF with reduced ejection fraction, regardless of diabetes status.

In March, the phase 3 DAPA-CKD trial was stopped early due to “overwhelming efficacy” in patients with chronic kidney disease.

“The phase 3 DAPA-MI trial is the first indication-seeking registry-based randomized controlled trial which will provide quicker access to data and reduce recruitment time and cost, while minimizing patient and investigator burden,” Mene Pangalos, PhD, executive vice president, BioPharmaceuticals R&D for AstraZeneca, said in a statement Thursday.