Friday, June 02, 2023
Esperion (NASDAQ: ESPR) has officially submitted Supplemental New Drug Applications (sNDAs) to the U.S. Food and Drug Administration (FDA) for their oral non-statin medications, NEXLETOL and NEXLIZET. The purpose of these applications is to expand the approved usage of both drugs to include cardiovascular risk reduction and eliminate the statin limitation in the indication for lowering low-density lipoprotein cholesterol (LDL-C). The submissions are supported by findings from the CLEAR Outcomes trial, which demonstrated significant reductions in cardiovascular risk associated with NEXLETOL across several primary and secondary endpoints.
Key results from the trial included a 27% decrease in the risk of non-fatal myocardial infarction, a 23% decrease in the composite of fatal and non-fatal myocardial infarction, a 19% decrease in the risk of coronary revascularization, a 15% decrease in the MACE-3 composite, and a 13% decrease in the MACE-4 composite. Esperion expects the FDA to review the applications and determine their completeness by mid-August 2023, with potential approval anticipated in the first half of 2024.
Sheldon Koenig, President and Chief Executive Officer of Esperion, expressed his enthusiasm for these submissions as a significant milestone that will expand the eligible patient population for NEXLETOL and NEXLIZET. He noted the increasing adoption of these treatments, as they are viewed as an important step following statin therapy due to their potential to substantially reduce cardiovascular risk.
NEXLETOL and NEXLIZET are currently approved as adjuncts to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional LDL-C lowering. The potential impact of these medications on cardiovascular morbidity and mortality is still being evaluated.
Please note that the information provided is based on available data up until September 2021. For the most recent updates and accurate details, it is recommended to refer to Esperion's official announcements or contact the company directly.