> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA OKs Esperion’s Combo Cholesterol Drug
- URL: https://www.fdaweb.com/fda-oks-esperions-combo-cholesterol-drug/
- Published: 2020-02-28T12:00:00.000Z
- Updated: 2026-09-14T16:04:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146206

FDA has approved an Esperion NDA for Nexlizet (bempedoic acid and ezetimibe) as an adjunct to diet and maximally tolerated statin therapy for treating adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease, who require additional lowering of LDL-C. Nexlizet is the first non-statin, LDL-C lowering combination medicine to be approved, the company SAYS. Its NDA for Nexletol (bempedoic acid) tablets was approved last week. Ezetimibe is the active ingredient in Merck’s Zetia.  

Nexlizet’s approval is supported by data from the company’s Phase 3 Fixed Combination Drug Product LDL-C Lowering program, as well as safety data from the Nexletol tablet global pivotal Phase 3 LDL-C lowering program and the existing ezetimibe safety profile, the company says. “Nexlizet lowered LDL-C by a mean of 38% compared to placebo when added on to maximally tolerated statins,” it says.