Labeling will change for two cholesterol-lowering medications

Effective immediately, FDA has changed the labels on two medications used to bring down LDL cholesterol levels: bempedoic acid (Nexletol) and bempedoic acid/ezetimibe (Nexlizet).

The new language identifies treatment of primary hyperlipidemia “as a qualifier for existing approved populations” and removes a requirement that patients reach their highest tolerated statin dose before initiating bempedoic acid.

Additionally, the update eliminates wording that underscored what previously was an uncertain CV benefit. Findings from the CLEAR Outcomes clinical study have since shown that the agents do indeed curtail CV risk, and full pending label approvals that reflect this evidence are expected within the first 3 months of the new year.