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DCGI okays AstraZeneca drug for treatment of heart failure in adults

DCGI approves AstraZeneca (images: Envato Elements, Pngtree)

The Drugs Controller General of India (DCGI) on July 24 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.

Fight against heart failure in India

Heart failure is a chronic, progressive disease affecting nearly 64 million people globally and about 10 million in India, and includes 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 randomized patients with left ventricular ejection fraction greater than 40%, 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). 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 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.

(Source: IANS)

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