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Disclosing data from a Phase 3 trial, AstraZeneca (NASDAQ:AZN) announced that its blockbuster diabetes therapy Farxiga (dapagliflozin) improved clinical outcomes in certain patients with heart failure (HF). The data were presented at the European Society of Cardiology Congress 2022 in Spain.
The 6,263-subject DELIVER trial involved HF patients with a left ventricular ejection fraction (LVEF) of over 40% with or without Type 2 diabetes.
LVEF measures the percentage of blood heart pumps when it contracts, and, according to Mene Pangalos, AZN’s Executive Vice President for Biopharma R&D, HF patients with LVEF of more than 40% represent the most difficult category to treat with limited therapeutic options,
The global study was designed to assess Farxiga, which belongs to a class of drugs called SGLT2 inhibitors, against a placebo.
The results indicated that the oral therapy significantly reduced a combined measure of cardiovascular (CV) death or worsening HF in patients with HF and mildly reduced or preserved ejection fraction (EF) against placebo.
Over a median follow-up of 2.3 years, Farxiga cut the composite outcome of CV death or worsening of HF by 18%, with a statistically significant result compared to placebo, the company said.
“These results from DELIVER are important for patients and clinical care as it shows that dapagliflozin is effective regardless of ejection fraction and therefore can be used as foundational therapy in all eligible patients with heart failure,” remarked Dr. Scott Solomon, a Professor of Medicine at the Harvard Medical School and the lead investigator of DELIVER.
In addition to type 2 diabetes mellitus, Farxiga is approved for HF patients with reduced EF of less than or equal to 40% and patients with chronic kidney disease.
Assuming a broader heart failure label for the drug based on these data, the addressable patient population for Farxiga will rise by 50%, Reuters reported quoting Ruud Dobber, the head of AZN biopharma business.
In 2021, Farxiga added more than $3.0B in revenue for the company with ~53% YoY growth.
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