FDA Approvals, Highlights, and Summaries: Cardiology 

February 24, 2021

Nexletol (bempedoic acid)

Bempedoic acid is a first-in-class adenosine triphosphate-citrate lyase (ACL) inhibitor that lowers low-density lipoprotein cholesterol (LDL-C) by inhibiting cholesterol synthesis in the liver. ACL is an enzyme upstream of 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase in the cholesterol biosynthesis pathway. Bempedoic acid and its active metabolite, ESP15228, require coenzyme A (CoA) activation by very long?chain acyl-CoA synthetase 1 (ACSVL1) to ETC-1002-CoA and ESP15228-CoA, respectively. ACSVL1 is expressed primarily in the liver, but absent in most peripheral tissues.

Bempedoic acid and the combination, bempedoic acid/ezetimibe, are indicated as an adjunct to diet and maximally tolerated statin therapy for adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C.

Approval of bempedoic acid was based on the phase 3 trials CLEAR Harmony and CLEAR Wisdom that included over 3000 patients. The addition of bempedoic acid to maximally tolerated statin therapy provided an average of 18% corrected LDL-C lowering. ( N Engl J Med. March 14, 2019;380(11);1022-1032; JAMA. November 12, 2019;322(18):1780-1788)

Other notable cardiovascular approvals

Brilinta (Ticagrelor) - New indication for risk reduction for patients with coronary artery disease who have not had a myocardial infarction or stroke; also indicated to reduce risk of stroke in patients with acute ischemic stroke or high-risk transient ischemic attack

Farxiga (dapagliflozin) - Indicated to reduce risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) (with or without diabetes) with reduced ejection fraction

Trulicity (dulaglutide) - Indicated for primary and secondary risk reduction of major adverse cardiovascular events in adults with type 2 diabetes who have established cardiovascular disease or multiple risk factors

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