FDA Updates Labels for Two Cholesterol-Lowering Agents

The US Food and Drug Administration (FDA) has approved an updated low-density lipoprotein (LDL)-cholesterol lowering indication for bempedoic acid (Nexletol) and the single-pill combination of bempedoic acid plus ezetimibe (Nexlizet).

The update adds treatment of primary hyperlipidemia “as a qualifier for existing approved populations,” the manufacturer, Esperion, explains in a news release.

Bempedoic acid and bempedoic acid/ezetimibe are indicated as adjuncts to diet and statin therapy for the treatment of primary hyperlipidemia in adults with heterozygous familial hypercholesterolemia (HeFH) or atherosclerotic cardiovascular disease who require additional lowering of LDL-C.

The FDA label update also removes the maximally tolerated statin requirement for use, as well as the prior limitation of use, which stated that the effect of bempedoic acid and bempedoic acid/ezetimibe on cardiovascular morbidity and mortality had not been determined.

The company says the updates are effective immediately and stem in part from FDA’s efforts to “modernize and synchronize” drug labels.

The company says the labeling changes do not affect the full pending label approvals for cardiovascular risk reduction indications for both drugs, “which remain on track for anticipated approval in the first quarter of 2024.”

Last spring, the company submitted four supplemental new drug applications (NDAs) based on results of the CLEAR Outcomes trial, which demonstrated that bempedoic acid can significantly reduce cardiovascular risk across a range of primary and second endpoints, as reported by Medscape Medical News.

The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date for the supplemental NDAs of March 31, 2024, according to the company.

Esperion press release: https://www.esperion.com/news-releases/news-release-details/us-fda-updates-ldl-c-lowering-indication-esperions-nexletolr