Esperion Says FDA Approves New Labels for Nexletol and Nexlizet
By Stephen Nakrosis
Esperion on Friday said the U.S. Food and Drug Administration approved new labels for both Nexletol and Nexlizet which make the treatments eligible for about 70 million patients in the U.S.
The new labels include indications for cardiovascular risk reduction and for and expanded LDL-C lowering, covering both primary and secondary prevention patients, the company said. Esperion also said the treatments are the oral non-statin LDL-C lowering drugs approved by the FDA for the reduction of CV events in both primary and secondary prevention patients.
Earlier today, the company said the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted positive opinions for label updates to both bempedoic acid and the bempedoic acid/ezetimibe fixed dose combination as treatments to reduce low-density lipoprotein cholesterol and cardiovascular risk.
Write to Stephen Nakrosis at stephen.nakrosis@wsj.com
(END) Dow Jones Newswires
March 22, 2024 16:06 ET (20:06 GMT)
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