The Drugs Controller General of India (DGCI) on Monday granted extended indication approval to AstraZeneca India’s Dapagliflozin in the treatment of heart failure in adults.
Dapagliflozin is already approved for heart failure patients with reduced ejection fraction. The additional indication will expand the indication for all types of heart failure irrespective of ejection fraction, the company said in a statement.
Heart failure is a chronic, progressive disease impacting nearly 64 million people globally and about 10 million in India, and comprises both heart failure with preserved ejection fraction and reduced ejection fraction.
The heart’s ejection fraction refers to the amount — or percentage — of blood pumped (or ejected) out of the heart’s left ventricle with each contraction. The approval is based on the results from the Phase III trial in 6,263 randomised patients with left ventricular ejection fraction greater than 40 per cent, with or without Type-2 diabetes.
The trial showed dapagliflozin is the only SGLT-2i with mortality benefits in the analysis of heart failure across left ventricular ejection fraction (LVEF). 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.
The available data from Indian heart failure registries show that they 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.
“Results from the study indicate Dapagliflozin’s positive and significant impact on patients with heart failure even when their ejection fraction is above 40 per cent. This approval reinforces our commitment to reducing the burden of this life-threatening disease and help patients across the heart failure spectrum live longer and healthier lives,” said Dr. Anil Kukreja, Vice-President, Medical Affairs and Regulatory, AstraZeneca India, in the statement.
“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,” added Dr Bagirath Raghuraman, Senior Consultant, Interventional & Transplant Cardiologist, Narayana Health, Bengaluru, who was part of the study.
2023072444629
