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Bempedoic Acid: First Approval.

Anthony Markham1

  • 1Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.

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Bempedoic acid, a novel antihyperlipidaemic drug, has gained approval for treating hypercholesterolaemia. Positive phase III CLEAR trial results supported its development and subsequent market authorization.

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Area of Science:

  • Cardiovascular pharmacology
  • Drug development and regulatory affairs

Background:

  • Hypercholesterolaemia remains a significant risk factor for cardiovascular disease.
  • Non-statin lipid-lowering therapies are crucial for managing cholesterol levels.
  • Bempedoic acid represents a new therapeutic option in antihyperlipidaemic treatment.

Purpose of the Study:

  • To summarize the key milestones in the development of bempedoic acid.
  • To highlight the clinical trial data leading to regulatory approvals.
  • To document the journey of bempedoic acid from development to market.

Main Methods:

  • Review of preclinical and clinical development data.
  • Analysis of phase III CLEAR clinical trial program findings.
  • Documentation of regulatory submission and approval processes in the USA and EU.

Main Results:

  • Bempedoic acid demonstrated efficacy in the CLEAR phase III clinical trial program.
  • Positive findings supported regulatory submissions for bempedoic acid.
  • Approvals were secured for both monotherapy and fixed-dose combination with ezetimibe.

Conclusions:

  • Bempedoic acid has successfully completed its development pathway.
  • The drug is now available as NEXLETOL/Nilemdo and NEXLIZET/Nustendi.
  • This marks a significant advancement in hypercholesterolaemia treatment options.