FDA greenlights first oral, daily, non-statin therapy for lowering LDL-Cholesterol

pharmafile | February 25, 2020 | News story | Manufacturing and Production, Sales and Marketing Esperion, FDA, Nexletol, pharma 

Esperion’s ATP Citrase Lyase (ACL) inhibitor Nexletol (bempedoic acid) has secured approval from the FDA, it has emerged. It is the first oral, daily, non-statin LDL-Cholesterol (LDL-C) lowering therapy approved in the US since 2002.

The drug is authorised as an adjunct to diet and maximally tolerated statin therapy as a treatment for heterozygous familial hypercholesterolemia (HeFH) or established atherosclerotic cardiovascular disease (ASCVD) in adult patients who require additional lowering of their LDL-C levels. 

It is estimated that around 15 million US patients can’t achieve recommended levels of LDL-C, even after receiving standard of care treatments like statin therapy. Build-up of the fatty substance is associated with increased risk of cardiovascular events such as heart attack or stroke.

Esperion’s drug was tested in Phase 3 trials in over 3,000 participants, where it was shown to lower LDL-C levels by 18% on average when combined with high or moderate intensity statins.

“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,” remarked Tim Mayleben, President and Chief Executive Officer 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. Today’s approval provides them with a new medicine to go along with a healthy diet. We express our sincere gratitude to all of the patients and physicians who put their confidence in Esperion’s team of lipid experts.”

The drug is expected to become available in US markets on 30 March.

Matt Fellows

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