AstraZeneca Pharma India Ltd. on Monday 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 company said in a statement.
The additional indication will expand the indication for all types of HF irrespective of ejection fraction. Dapagliflozin is the only SGLT-2i which has shown mortality benefits in the pooled analysis of heart failure across LVEF, it added.
Heart failure is a chronic, progressive disease impacting nearly 64 million people globally and about 10 million in India, which comprises of both heart failure with preserved ejection fraction and reduced ejection fraction.
“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. Bagirath Raghuraman, Sr. consultant Interventional & Transplant cardiologist, Narayana Health, Bangalore, said in a statement.
The available data from Indian HF registries show that HF patients in India are younger by 10-years, and the majority of the burden lies below 65 years of age, as compared to the patients from high-income countries.
“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,” Dr. Anil Kukreja, Vice-President, Medical Affairs and Regulatory, AstraZeneca India, said in a statement.
With a concentrated focus and efforts towards delivery research and science-based solution, AstraZeneca’s DapaCare is a robust programme of clinical trials to evaluate the potential CV, renal and organ protection benefits of dapagliflozin, the pharma major claimed.
It includes more than 35 completed and ongoing Phase IIb/III trials in more than 35,000 patients, as well as more than 2.5 million patient-years’ experience. Moreover, Dapagliflozin is currently being tested in patients without T2D following an acute myocardial infarction or heart attack in the DAPA-MI Phase III trial – a first of its kind, indication-seeking registry-based randomised controlled trial, it stated.