Bempedoic acid nears Korean approval for lipid-lowering treatment

A new non-statin oral lipid-lowering drug will likely enter the Korean clinical market.

The Ministry of Food and Drug Safety is reviewing bempedoic acid for approval. If approved, it will expand treatment options for statin-intolerant and high-risk patients.

Bempedoic acid reduces LDL-C and major cardiovascular risks. The drug is already available in the U.S. and Europe and is newly recommended in European dyslipidemia guidelines, confirming its therapeutic role.

The European Society of Cardiology (ESC) and European Atherosclerosis Society (EAS) have published an update to the 2019 dyslipidemia guidelines, stressing more precise patient risk assessment and optimal early treatment.

SCORE2-based precision risk assessment enables accurate risk stratification in the elderly

The updated guidelines use SCORE2 and SCORE2-OP (for those ≥70 years) to assess 10-year risks of fatal and non-fatal ASCVD. They also add modifiers for risk factors not captured by SCORE2 alone.

Professor Kim Sang-hyun of SNU–SMG Boramae Medical Center, president of the Korean Society of Lipid and Atherosclerosis, explained that the updated guidelines improve risk assessment by considering the likelihood of death from cardiovascular disease as well as the chances of developing serious conditions such as myocardial infarction or stroke.

Professor Kim noted that the assessment age range has been expanded to include patients under 90 years old, enabling elderly patients to more precisely determine their risk level. The precision of risk assessment has been enhanced by utilizing a more accurate measure of “bad cholesterol” alongside vascular calcification and blood test indicators.

"Most notably, bempedoic acid is now considered on par with ezetimibe," Kim emphasized.

These guidelines strengthen recommendations for proven non-statin agents. They now include bempedoic acid for statin-intolerant patients and those not reaching LDL-C goals on statins, regardless of ezetimibe use.

This is based on the CLEAR Outcomes study, which included 13,970 high-risk, statin-intolerant patients. Bempedoic acid reduced LDL-C by 22 mg/dL and major cardiovascular events by 13 percent.

"Bempedoic acid lowers muscle side-effect risk with its liver-specific activation. It addresses statin intolerance and may reduce cardiovascular risk. Its ability to lower hsCRP and avoid affecting blood glucose means it may be increasingly needed for certain groups," Professor Kim explained.

Emphasis on faster and more aggressive LDL-C control

While the LDL-C target level itself remains unchanged from previous guidelines, this update emphasizes that how quickly and to what extent that target is reached is now more critical.

For example, in patients with acute coronary syndrome (ACS), the guidelines propose an immediate LDL-C-lowering strategy starting at admission, rather than a stepwise approach. They also specify that statin therapy should be initiated without delay in the primary prevention stage for other high-risk groups.

With new lipid-lowering agents and earlier combination therapy, options for achieving LDL-C targets quickly and reliably have expanded.

"The revised guidelines focus on how quickly the LDL-C target is reached and treatment intensity," Kim explained. "As a result, early combination therapy and new agents will likely become more common."

Industry insiders said that approval of bempedoic acid in Korea could address unmet needs in high-risk and statin-intolerant patients. It would also enable earlier and more intensive combination therapy in line with the 2025 ESC/EAS guidelines, they added.