Bempedoic acid (Nexletol, Esperion), an oral, once-daily, non-statin low-density lipoprotein-cholesterol (LDL-C)-lowering medicine, is now available in US pharmacies, according to a press release.
Bempedoic acid, which was approved in February 2020, 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 lowering of LDL-C.
A first-in-class ATP citrate lyase (ACL) inhibitor, bempedoic acid lowers LDL-C by reducing cholesterol biosynthesis and up-regulating LDL receptors. Phase 3 studies included more than 3000 patients, with more than 2000 patients treated with bempedoic acid. Studies showed that bempedoic acid significantly reduced LDL-C on background maximally-tolerated statin therapy compared with a placebo, which was durable through 52 weeks. Overall adverse effect rates were comparable with placebo.
In phase 3 studies conducted in more than 3000 patients, over 2000 patients treated with bempedoic acid demonstrate an average 18% placebo-corrected LDL-C lowering when used in patients on moderate- or high-intensity statins.
“There were no new oral non-statin options for LDL-C lowering in nearly 20 years, and we know Nexletol is an anticipated solution for the appropriate patients that have not been able to reach their LDL-C goals and could benefit from Nexletol immediately,” Mark Glickman, chief commercial officer of Esperion, said in a statement.
To provide access and affordability, bempedoic acid is available of a list price of approximately $10 per day to payers, and eligible patients with commercial drug insurance coverage may pay as little as $10 per fill, up to a 3-month supply, according to Esperion.
“We recognize this is an incredibly demanding time for health care providers and are committed to respecting their time by adapting our introduction of Nexletol to provide the most flexible learning approach possible,” Glickman said. “We are convinced as the health care community begins to discover the benefits of this medicine for their patients, it will become clear the immediate future should be brighter for many people battling bad cholesterol.”
1. Esperion Announces Commercial Availability of the Nexletol (bempedoic acid) Tablet and Pledges a Conscientious Launch During Unprecedented Moment in Healthcare [news release]. Esperion’s website. https://www.esperion.com/investors-media/press-releases/. Accessed April 1, 2020.