First non-statin cholesterol lowering drug approved in nearly 20 years

Pharma News: Esperion’s Nexletol (bempedoic acid) is the first oral, once-daily, non-statin LDL-C lowering medicine FDA approved since 2002.

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.

Nexletol is a first-in-class ATP Citrate Lyase (ACL) inhibitor that lowers LDL-C by inhibition of cholesterol synthesis in the liver.

“Nexletol delivers a new treatment alternative if they struggle with bad cholesterol and have ASCVD or HeFH,” said Tim Mayleben, president and chief executive officer of Esperion. “Even with maximally tolerated statins, some of these patients can’t achieve their LDL-C goals.”

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The approval of Nexletol is supported by a global pivotal Phase 3 LDL-C lowering program conducted in more than 3,000 patients. In these studies,
Nexletol provided an average of 18% placebo corrected LDL-C lowering when used with moderate or high intensity statins. Results from the Phase III development program have been published in The New England Journal of Medicine (040 Study), and The Journal of the American Medical Association (047 Study).

Nexletol will be commercially available in the U.S., by prescription only, on March 30, 2020.

The company has a large study underway to see whether Nexletol can lower the risk of heart attacks and other problems, not just cholesterol. Results are expected late in 2022.

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