FDA approves expanded labels for Esperion’s cholesterol drugs
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ANN ARBOR, Mich. – Esperion (NASDAQ:ESPR) Therapeutics (NASDAQ:ESPR) announced today that the U.S. Food and Drug Administration (FDA) has approved new label expansions for its cholesterol-lowering medications, NEXLETOL® (bempedoic acid) Tablets and NEXLIZET® (bempedoic acid and ezetimibe) Tablets.
These approvals, based on the CLEAR Outcomes trial data, allow the drugs to be used for cardiovascular risk reduction and to treat a broader range of patients with high cholesterol.
The expanded labels now include indications for the reduction of low-density lipoprotein cholesterol (LDL-C) in primary and secondary prevention patients, with or without concomitant statin therapy. This marks the first time that non-statin oral medications have been approved for reducing cardiovascular risk in both primary and secondary prevention patients.
Sheldon Koenig, President and CEO of Esperion, expressed confidence that these approvals will increase accessibility to NEXLETOL and NEXLIZET for over 70 million potential patients in the U.S. The company has prepared for these approvals by increasing its sales force and enhancing patient support programs.
The positive results from the CLEAR Outcomes trial, published in the New England Journal of Medicine in March 2023, demonstrated the drugs’ safety and effectiveness. The trial, which included nearly 14,000 patients, showed a 20% reduction in LDL-C, 22% reduction in high-sensitivity C-reactive protein (hsCRP), and no elevation in glucose levels when compared to placebo.
Esperion also received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on March 21, 2024, and anticipates a final determination from the European Medicines Agency in the second quarter of 2024.
The company is set to host a conference call and webcast on Monday to discuss the FDA approvals and the expanded indications for its drugs. This article is based on a press release statement from Esperion Therapeutics.
