FDA clears new type of cholesterol drug

FDA has approved bempedoic acid (Nexletol—Esperion Therapeutics), a new cholesterol medicine. Taken once a day, bempedoic acid is the first oral non-statin approved in nearly 20 years. The drug is viewed as an alternative for millions of patients who are unable to take or do not respond to statins.

FDA has approved bempedoic acid (Nexletol—Esperion Therapeutics), a new cholesterol medicine. Taken once a day, bempedoic acid is the first oral non-statin approved in nearly 20 years. The drug is viewed as an alternative for millions of patients who are unable to take or do not respond to statins. In clinical trials, the drug was shown to reduce low-density lipoprotein cholesterol (LDL-C) levels when taken alone as well as in addition to other lipid-lowering therapies. Bempedoic acid inhibits a specific enzyme in the liver that enables LDL to exit the bloodstream. Esperion says in late-stage trials, bempedoic acid reduced LDL-C levels an average 18% compared with placebo in patients taking moderate- and high-dose statins, and up to 28% in patients taking low-dose or no statins. A combination drug consisting of bempedoic acid and ezetimibe, another cholesterol-lowering drug, was found to reduce LDL-C levels by 38% in patients taking a recommended standard dose or low dose of statins, and 44% in patients taking no statins. A decision on the combination therapy is expected soon. In its approved label, FDA warned of elevated uric acid levels and increased risk of ruptured tendons. Esperion said bempedoic acid was generally well-tolerated in clinical studies, but did not disclose a price for the drug, which it intends to launch in late March. Some analysts predict bempedoic acid will cost $3,500 annually prior to discounts or insurance.