Bempedoic Acid: First Approval

2020-04-20T23:52:02Z (GMT) by Anthony Markham

Compliance with Ethical Standards


Funding: The preparation of this review was not supported by any external funding.


Conflict of interest: During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. A. Markham, a contracted employee of Adis International Ltd/Springer Nature, is responsible for the article content and declares no relevant conflicts of interest.


Additional information about this Adis Drug Review can be found here


Abstract

Bempedoic acid is a non-statin antihyperlipidaemic drug being developed by Esperion Therapeutics for the treatment of hypercholesterolaemia. Based on positive findings in the phase III CLEAR clinical trial programme, bempedoic acid has been approved in the USA and in the EU as monotherapy (NEXLETOL® in the USA, Nilemdo® in the EU) and as a fixed dose combination with ezetimibe (NEXLIZET® in the USA, Nustendi® in the EU). This article summarizes the milestones in the development of bempedoic acid leading to these frst approvals.


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