FDA approves oral, non-statin LDL-Cholesterol (LDL-C) lowering treatment bempedoic acid (Nexletol)

Approval is supported by phase III LDL-C lowering program conducted in more than 3000 patients, which showed an average of 18% placebo corrected LDL-C lowering when used with moderate or high-intensity statins, and by 25% in patients not on statin due to intolerance vs. placebo.

SPS commentary:

Bempedoic acid is a first-in-class ATP Citrate Lyase (ACL) inhibitor that lowers LDL-C by inhibition of cholesterol synthesis in the liver. In January 2020, the Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the granting of a marketing authorisation in EU, for the treatment of adults with primary hypercholesterolaemia (heterozygous familial and non‑familial) or mixed dyslipidaemia.


Biospace Inc.