FDA Approves Non-Statin Option for LDL-C Reduction

The US Food and Drug Administration has approved Nexletol (bempedoic acid) for lowering low-density lipoprotein cholesterol (LDL-C) in adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease as an adjunct to diet and maximally tolerated statin therapy.

Nexletol is a once-daily, oral tablet that is a first-in-class ATP citrate lyase inhibitor.

The safety and efficacy of the drug was examined in a phase 3 trial of more than 3000 patients. Overall, when combined with moderate- or high-intensity statins, Nexletol provided a mean 18% placebo-corrected LDL-C reduction.

Label warnings and precautions for Nexletol include hyperuricemia, gout, and risk of tendon rupture or injury. Adverse events reported in the trial included upper respiratory tract infections, muscle spasms, hyperuricemia, back pain, abdominal pain, bronchitis, pain in extremity, anemia, and elevated liver enzymes. The majority of adverse events were balanced in occurrence with those in patients taking placebo.

—Michael Potts

Reference:
Esperion Announces FDA Approval of NEXLETOL™ (bempedoic acid) Tablet, an Oral, Once-Daily, Non-Statin LDL-Cholesterol Lowering Medicine. News release. Esperion. February 21, 2020. Accessed February 24, 2020. https://esperion.gcs-web.com/node/11206/pdf.