AZ’s Farxiga becomes first FDA-approved SGLT2 inhibitor for heart failure with reduced ejection fraction
The FDA has moved to approve an oral tablet formulation of AstraZeneca’s Farxiga (dapagliflozin) to reduce the risk of cardiovascular death and hospitalisation in adult patients with New York Heart Association’s functional class II-IV heart failure with reduced ejection fraction.
The decision makes the drug the first sodium-glucose co-transporter 2 (SGLT2) inhibitor available in the US in this indication.
The approval, made under the US regulator’s Priority Review pathway, was based on clinical trial data drawn from the drug’s use in 4,744 participants with an average age of 66 years, 77% of which were male. The findings showed that, after 18 months of treatment, patients receiving 10mg Farxiga experienced fewer cardiovascular deaths and hospitalisations or urgent visits as a result of heart failure compared to those receiving placebo.
“Heart failure is a serious health condition that contributes to one in eight deaths in the US and impacts nearly 6.5 million Americans,” remarked Dr Norman Stockbridge, Director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research. “This approval provides patients with heart failure with reduced ejection fraction an additional treatment option that can improve survival and reduce the need for hospitalisation.”
Farxiga is already approved by the FDA for the improvement of glycaemic control in adult type 2 diabetes patients when paired with diet and exercise, and to reduce hospitalisation risk from heart failure type 2 diabetes and known cardiovascular disease. AstraZeneca also recently confirmed it is testing the drug for efficacy in treating COVID-19 in patients with existing heart and kidney conditions.
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