AstraZeneca PLC said Monday that its Forxiga drug has been recommended for approval in the European Union for certain types of heart failure.
The recommendation covers heart failure with reduced ejection fraction–a measure of the amount of blood the heart’s left ventricle pumps with each heartbeat.
The Anglo-Swedish pharma giant
said the Committee for Medicinal Products for Human Use of the European Medicines Agency based its opinion on results from the Deliver Phase 3 trial.
The company said that if approved Forxiga will be the first heart-failure therapy indicated across the full ejection fraction range with a proven mortality reduction.
“If approved for this new, broader indication for heart failure with mildly reduced or preserved ejection fraction, more patients will be able to benefit from this well-tolerated and guideline-directed treatment,” the company said.
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