Tag: CHMP

CHMP issues positive opinion to expand Jardiance (empagliflozin) indication based on unprecedented benefit in adult heart failure patients with preserved ejection fraction

Coronary/Structural Heart by 0 comments

– The positive opinion is based on the landmark EMPEROR-Preserved Phase III trial, which showed significant outcomes in patients with heart failure with left ventricular ejection fraction over 40%1 – If approved, Jardiance would be the first and only clinically proven treatment […]

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Esperion Announces Positive CHMP Opinion for the Marketing Authorization Application for the Bempedoic Acid / Ezetimibe Fixed Dose Combination Tablet for the Treatment of Hypercholesterolemia and Mixed Dyslipidemia

Coronary/Structural Heart by 0 comments

–  Bempedoic Acid / Ezetimibe Fixed Dose Combination Tablet is an Oral, Once-Daily, Non-Statin Medicine that Lowers Bad Cholesterol with a First-in-Class Mechanism  – –  Positive CHMP Opinion is Based on the Completed Pivotal Phase 3 Fixed Dose Combination Tablet LDL-Cholesterol Lowering […]

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CHMP issues positive opinions for both bempedoic acid and the bempedoic acid / ezetimibe fixed dose combination tablet as treatments for hypercholesterolaemia

Coronary/Structural Heart by 0 comments

Bempedoic acid is an oral, once-daily ATP citrate lyase inhibitor that reduces cholesterol synthesis in the liver. This unique mechanism of action is complementary to statins and other lipid-lowering therapies1 Positive CHMP opinions are based on a global clinical trial […]

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