FDA approves daily cholesterol pill that works differently from statins

The FDA broadened the labels for Nexletol and Nexlizet in March 2024, clearing the daily cholesterol medicines to help prevent heart attacks and cardiovascular procedures in both primary and secondary prevention patients, whether or not they take statins. That puts bempedoic acid, the drug sold as Nexletol, among the options for people whose cholesterol remains high despite standard therapy or who cannot tolerate statins well enough to stay on them.

Bempedoic acid lowers cholesterol in a different way from statins and is not associated with the statin muscle side effect that often drives patients off treatment. Esperion Therapeutics puts the expanded labels at about 70 million patients in the United States and calls Nexletol the first LDL-C-lowering non-statin indicated for primary prevention patients. The FDA’s prescribing information for both Nexletol and Nexlizet covers indications and usage, dosage and administration, contraindications, and warnings and precautions.

Statins remain the first-line treatment for many patients, especially those with established cardiovascular disease or very high LDL levels. Nexletol fits where statins fall short: patients who do not get enough LDL reduction, patients who cannot tolerate statins, and patients in primary prevention who need more protection before a first heart attack or procedure. The approval followed positive CLEAR Outcomes data, which supported the expanded cardiovascular-risk reduction indication.

Nexletol was first approved by the FDA on February 21, 2020, as the first oral, once-daily, non-statin LDL-cholesterol-lowering medicine approved in the United States in nearly 20 years. That once-a-day dosing makes it easier to add than injectables or complex regimens, but access still hinges on insurance. Esperion offers patient financial support, prior authorization assistance, and reimbursement resources.

Drug pricing sites list Nexletol at about $431 for a 30-tablet supply, depending on the pharmacy, while one coupon service lists a lowest price of $390.48 for 30 tablets and some Medicare prescription drug plans may cover it.