INDIA – AstraZeneca Pharma India Ltd. (AstraZeneca India), a science-led biopharmaceutical company, has achieved a major milestone with its drug, Dapagliflozin, indicated for adult patients with heart failure (HF).
The Drugs Controller General of India (DGCI) has granted an extended indication approval for AstraZeneca’s Dapagliflozin.
DGCI has given AstraZeneca’s Dapagliflozin the green light to be marketed as a first-line treatment for heart failure in adults.
This approval reinforces the pharmaceutical company’s commitment to reducing the burden of this chronic, long-term condition and helping patients across the HF spectrum live longer and healthier lives.
On his part, Dr. Anil Kukreja, Vice-President for Medical Affairs and Regulatory at AstraZeneca India, said: “We are committed to pushing the boundaries of science and bringing the best-in-class life-changing original research medicines for patients across the world including in India.
The additional indication 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%.
DELIVER was an international, randomized, double-blind, parallel-group, placebo-controlled, event-driven Phase III trial.
This drug trial was designed to evaluate the efficacy of dapagliflozin, compared with a placebo, in the treatment of HF patients with LVEF greater than 40%, with or without T2D.
Analyses of the DELIVER Phase III trial show one possible reason attributed to the additional indication approval for the treatment of heart failure in adults in India.
Dapagliflozin is the only SGLT-2i that has shown mortality benefits in the pooled analysis of heart failure across the left ventricular ejection fraction.
AstraZeneca has a robust programme of clinical trials to evaluate the potential cardiovascular, renal, and organ protection benefits of dapagliflozin called DapaCare.
AstraZeneca’s DapaCare 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.
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 randomized controlled trial.
“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%,” noted Dr. Kukreja.
In clinical trials, researchers found that AstraZeneca’s original research product dapagliflozin showed consistent results across pre-defined subgroups.
AstraZeneca’s original research product dapagliflozin significantly reduced the composite of cardiovascular death or worsening heart failure in patients with HF with mildly reduced or preserved ejection fraction (EF), compared to placebo.
While Dapagliflozin is already approved for HF with reduced ejection fraction, the additional indication will expand the indication for all types of HF irrespective of ejection fraction.
Commenting on the disease burden, Dr. Bagirath Raghuraman, a Senior Consultant Interventional & Transplant cardiologist at Narayana Health, Bangalore, said: “Heart Failure is a condition which has high mortality rates irrespective of ejection fraction. Despite this, it is not well recognized or diagnosed.”
Heart failure is a chronic, progressive disease impacting nearly 64 million people globally and about 10 million in India, which comprises both heart failure with preserved ejection fraction and reduced ejection fraction.
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.
The extended indication approval from DGCI allows treatment of heart failure patients irrespective of the ejection fraction based on a new trial DELIVER conducted by AstraZeneca India.
“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,” outlined Dr. Raghuraman.
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