FDA clears first-in-class high cholesterol drug
Treatment is first non-statin LDL-C lowering treatment approved in years.
A first-in-class, non-statin drug to lower cholesterol will soon be on the market after receiving FDA approval
The agency cleared bempedoic acid (Nexletol, Esperion), an oral, once-daily, non-stain, LDL-Cholesterol lowering medication. The drug is a first-in-class ATP Citrate Lyase (ACL) inhibitor that lowers LDL-C by inhibition of cholesterol synthesis in the liver, Esperion said in a press release.
Related: Top 3 Drugs Expected In First Half 2020
Nexletol is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or established atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of LDL-C.
It is the first oral, once-daily, non-statin LDL-C lowering medicine approved since 2002 for indicated patients, Esperion said. It will be on the market on March 30.
“Nexletol delivers upon a commitment we’ve made to millions of patients for a new treatment alternative if they struggle with bad cholesterol and have ASCVD or HeFH,” says Tim Mayleben, president and CEO of Esperion. “Even with maximally tolerated statins, which may mean no statin at all, some of these patients can’t achieve their LDL-C goals.”
Related: FDA Okays New Indication For Fish Oil Drug
Despite standard of care treatments, including statin therapy, it is estimated that nearly 15 million patients in the US cannot achieve guideline recommended LDL-C levels, according to Esperion.
The approval of Nexletol is supported by a global pivotal Phase 3 LDL-C lowering program conducted in more than 3,000 patients. Nexletol provided an average of 18% placebo corrected LDL-C lowering when used with moderate or high intensity statins.
Esperion said it is working with health insurance providers to “help ensure broad insurance coverage and patient access to Nexletol.” Plus, it is committed to achieving the lowest branded tier coverage for Medicare patients.
Read more: Blockbuster Diabetes Drug Snags New Heart Indication
Newsletter
Get the latest industry news, event updates, and more from Managed healthcare Executive.
PBM-Offered Genomics Testing Could Reshape Prescribing of Medications
August 1st 2025Two PBMs, True Rx Health Strategies and Capital Rx, are using pharmacogenomics — how a person’s DNA affects their response to medications — to reduce the trial-and-error of prescribing medications, saving employers and patients time and money.
Read More
FDA Extends Review of Blenrep Combinations in Multiple Myeloma
August 1st 2025Last week, an FDA advisory committee against the risk-benefit profile of Blenrep in combination with other therapies. Regulators and reviewers were concerned about the ocular side effects and dosing and tolerability. The new action date is Oct. 23, 2025.
Read More
Sarepta to Pause Shipments of the Gene Therapy Elevidys
August 1st 2025Sarepta officials said the temporary halt in shipments was done to maintain a productive working relationship with regulators while they address a safety labeling update about the risk of acute liver disease related to Elevidys.
Read More
