AstraZeneca has announced positive results from the Phase III DAPA-HF trial, in which Forxiga (dapagliflozin) showed a statistically-significant and clinically-meaningful reduction of cardiovascular death or the worsening of heart failure.
The trial was conducted in patients with reduced ejection fraction (HFrEF) on standard of care treatment, including those with and without Type II diabetes.
The study is the first heart failure outcomes trial with an SGLT2 inhibitor investigating the treatment of heart failure in adults with HFrEF on top of standard of care to include those with and without Type II.
Forxiga has had a string of successes recently, as it was recommended by The National Institute of Health and Care Excellence (NICE) as an option for adults with type I diabetes in July, and the European Commission approved an update to the drug’s marketing authorisation earlier this month.
With the results, the treatment becomes “the first in its class to demonstrate efficacy and safety data for the treatment of patients with heart failure, with and without Type II diabetes, on top of standard of care”, explained Mene Pangalos, executive vice president of BioPharmaceuticals R&D.
He continued to say, “Today, half of heart failure patients will die within five years of diagnosis and it remains one of the leading causes of hospitalisation” and said that the company “look forward to discussing the results of DAPA-HF with health authorities as soon as possible.”
The drug was, however, hit with a US Food and Drug Administration (FDA) Complete Response Letter regarding the supplemental New Drug Application in July, meaning the governing body initially rejected the treatment.