Bempedoic acid + ezetimibe

Unassigned

New Medicines

Hypercholesterolaemia, atherosclerotic cardiovascular disease (ASCVD) and/or heterozygous familial hypercholesterolemia (HeFH)

Information

New formulation
Esperion
Esperion

Development and Regulatory status

Pre-registration (Filed)
Pre-registration (Filed)
Phase III Clinical Trials

Mar 19: EU Marketing Authorisation Application validated by EMA [5].


Mar 18: Esperion Therapeutics intends to submit a Marketing Authorization Application (MAA) for bempedoic acid/ezetimibe to the EMA by Q2 2019, and to file in the US in Q1 19 [3].

Category

First-in-class, non-statin targeted therapy that works in the liver to block cholesterol biosynthesis (bempedoic acid) plus a selective inhibitor of intestinal absorption of cholesterol and related phytosterols (ezetimibe).
Over half of all adults in England have raised cholesterol (>5mmol/L). Genetically inherited high cholesterol, or familial hypercholesterolemia, affects 1 in 250 or approximately 260,000 people in the UK [1].
Hypercholesterolaemia, atherosclerotic cardiovascular disease (ASCVD) and/or heterozygous familial hypercholesterolemia (HeFH)
Oral

Evidence based evaluations

NIHR