FDA Approves Bempedoic Acid for Treatment of Adults With HeFH or Established ASCVD

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The U.S. Food and Drug Administration has approved bempedoic acid (Nexletol) for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or established atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of LDL-C. The recommended dosage for the new drug, in combination with maximally tolerated statin therapy, is 180 mg administered orally once daily.

The label recommends analyzing lipid levels within 8 to 12 weeks of initiation and to avoid concomitant use of bempedoic acid with simvastatin greater than 20 mg and with pravastatin greater than 40 mg. It also includes warnings that bempedoic acid may increase blood uric acid levels and risk of tendon rupture or injury.

Recent studies like CLEAR Wisdom presented at ACC.19 in New Orleans have shown bempedoic acid offers a safe and effective oral therapeutic option for lipid lowering in patients who cannot tolerate statins. However, the drug label notes "the effect of NEXLETOL on cardiovascular morbidity and mortality has not been determined."

Read the complete label.

Clinical Topics: Dyslipidemia, Lipid Metabolism, Nonstatins, Primary Hyperlipidemia

Keywords: ACC Advocacy, Hyperlipoproteinemia Type II, Cholesterol, LDL, United States Food and Drug Administration, Atherosclerosis

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