AstraZeneca Pharma India (AstraZeneca India), a science-led biopharmaceutical company, announced it has received extended indication approval from the Drugs Controller General of India (DCGI) for its drug, Dapagliflozin in the treatment of heart failure (HF) in adults.

The approval is based on the detailed results from the DELIVER Phase III trial—the largest and broadest HF trial to date in patients with LVEF (left ventricular ejection fraction)> 40%.

AstraZeneca’s original research product dapagliflozin significantly reduced the composite of cardiovascular (CV) death or worsening heart failure in patients with HF with mildly reduced or preserved ejection fraction (EF), compared to placebo. The results were consistent across pre-defined subgroups. Dapagliflozin is already approved for HF with reduced ejection fraction. The additional indication will expand the indication for all types of HFirrespective of ejection fraction. Dapagliflozin is the only SGLT-2i which has shown mortality benefits in the pooled analysis of heart failure across LVEF.

Dr. Bagirath Raghuraman, Sr. consultant Interventional & Transplant cardiologist, Narayana Health, Bangalore, said, “Heart Failure is a condition which has high mortality rates irrespective of ejection fraction. Despite this, it is not well recognised or diagnosed. All people with breathlessness should be evaluated with a simple blood test and echocardiogram to rule out heart failure. This approval is significant for heart failure patients specifically for patients with preserved ejection fraction who have limited treatment options.”

Dr. Anil Kukreja, Vice-President, Medical Affairs and Regulatory, AstraZeneca India, added: “We are committed to push the boundaries of science and bring the best-in-class life changing original research medicines for patients across the world including in India. Our ground-breaking results from the DELIVER study indicates Dapagliflozin’s positive and significant impact on patients with heart failure even when their ejection fraction is above 40%. This approval reinforces our commitment to reducing the burden of this life- threatening disease and help patients across the HF spectrum live longer and healthier lives.”