AstraZeneca’s heart disease drug meets key endpoints in Phase III
pharmafile | May 6, 2022 | News story | Medical Communications |
AstraZeneca’s treatment for heart disease has delivered positive high-level results from its Phase III DELIVER trial.
Farxiga (dapagliflozin) is already approved for indications related to Type 2 diabetes, heart failure (HF) with reduced ejection fraction, and chronic kidney disease. The DELIVER study, involving 6,263 randomised participants, evaluated the drug’s efficacy on patients with heart failure with mildly reduced or preserved EF, defined as a left ventricular ejection fraction greater than 40%, compared to placebo.
The treatment demonstrated a statistically significant and clinically meaningful reduction in cardiovascular death or worsening heart failure, which was its primary endpoint.
“We are delighted to have met the primary endpoint in this patient population which has few treatment options. DELIVER is the largest and broadest trial to date in heart failure with mildly reduced or preserved ejection fraction. The results of DELIVER extend the benefit of dapagliflozin to the full spectrum of patients with heart failure,” Dr Scott Solomon, the study’s principal investigator and professor at the Harvard Medical School and Brigham and Women’s Hospital said in a statement.
“Today’s groundbreaking results coupled with those from the DAPA-HF trial show that FARXIGA is effective in treating heart failure regardless of ejection fraction. These data build upon our previous studies demonstrating cardiorenal protection across patients with either diabetes, chronic kidney disease or heart failure,” Mene Pangalos, executive vice president of biopharmaceutical R&D at AstraZeneca said.
Full results of the DELIVER Phase III study will be presented at upcoming medical meetings, and regulatory submissions are currently underway.
Lina Adams
