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
Related Content
Amphista doses first patient in AML trial of protein degrader
Amphista Therapeutics has dosed the first patient in a phase 1 trial of AMX-883, an …
Pharma sees climate disruption as growing supply-chain risk
Nine in ten pharmaceutical companies across the UK and G7 countries expect climate-related disruption to …
AI in pharma: From lab development to patient impact
In the decade to 2025, AI use in vaccine development has increased markedly but is …
