Daiichi Sankyo Europe GmbH and Esperion Therapeutics, Inc. have made a joint announcement regarding the recent developments related to bempedoic acid (marketed as NILEMDO®) and the bempedoic acid/ezetimibe fixed combination tablet (marketed as NUSTENDI®) in the European market. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued statements updating the labels of these medications, confirming their approval as treatments to lower low-density lipoprotein levels (LDL-C) and reduce cardiovascular risk.
The existing labeling of bempedoic acid (NILEMDO®) has been expanded to include approval for adults with primary hypercholesterolemia (both heterozygous familial and non-familial) or mixed dyslipidemia as an adjunct to diet. This approval encompasses its use in combination with a statin or other lipid-lowering therapies for patients who cannot achieve their LDL-C goals with a statin alone, as well as for patients who are intolerant to statins or for whom a statin is contraindicated. The CHMP has recommended updating this label to also indicate bempedoic acid’s effectiveness in reducing cardiovascular risk in adults with established or increased risk of atherosclerotic cardiovascular disease when used as an adjunct to correcting other risk factors. This recommendation includes using bempedoic acid in combination with ezetimibe for patients intolerant to statins or for whom a statin is contraindicated.
Similarly, the labeling for bempedoic acid/ezetimibe fixed combination tablets (NUSTENDI®) has been updated to authorize their use in adults with primary hypercholesterolemia or mixed dyslipidemia. This authorization includes using the combination with a statin and ezetimibe for patients who cannot achieve their LDL-C goals with a statin alone, as well as for patients intolerant to statins or for whom a statin is contraindicated and who cannot achieve their LDL-C goals with ezetimibe alone. The CHMP also recommends updating the package leaflet of bempedoic acid/ezetimibe to reflect its efficacy in reducing cardiovascular risk in specific patient groups.
Oliver Appelhans, Head of Europe Specialty Division at Daiichi Sankyo Europe GmbH, expressed enthusiasm about the positive CHMP opinion, emphasizing the milestone it represents in addressing the unmet need for cardiovascular care and prevention in Europe. He highlighted the effectiveness of bempedoic acid in reducing hypercholesterolemia and preventing cardiovascular risks, underscoring the commitment to improving cardiovascular treatment outcomes.
Sheldon Koenig, President and CEO of Esperion, also welcomed the positive CHMP opinion, noting the significant benefits of bempedoic acid in reducing cardiovascular risk globally. He emphasized that this approval milestone strengthens their efforts to develop innovative treatment options for managing cardiovascular risk in patients with elevated LDL-C.
The CHMP’s positive opinions are based on the analysis of the phase 3 CLEAR Outcomes study, involving a substantial number of participants across multiple countries. The study demonstrated a significant reduction in major cardiovascular events, further supporting the efficacy and safety profile of bempedoic acid and its combination with ezetimibe.
The European Commission will review the CHMP’s opinions and is expected to make its final decision regarding these label updates in mid-2024.
