FDA approves expansive label updates for Esperion’s NEXLETOL and NEXLIZET
In a significant advancement for heart health management, Esperion (NASDAQ: ESPR) has announced that the United States Food and Drug Administration (FDA) has approved comprehensive label expansions for its flagship products, NEXLETOL (bempedoic acid) Tablets and NEXLIZET (bempedoic acid and ezetimibe) Tablets. This approval, rooted in the positive data from the CLEAR Outcomes trial, heralds a new phase in the treatment of cardiovascular diseases and LDL-C (Low-Density Lipoprotein Cholesterol) management, impacting both primary and secondary prevention patients.
The recent FDA approval enables a broadened use of NEXLETOL and NEXLIZET, introducing them as viable options for cardiovascular risk reduction and expanded LDL-C lowering. This marks a pivotal shift, making these drugs the only LDL-C lowering non-statin options indicated for primary prevention in patients who are at high risk of cardiovascular events but have not yet experienced one. Moreover, the updated labels advocate for the use of NEXLETOL and NEXLIZET alone or in combination with statins, significantly broadening their accessibility to over 70 million eligible patients in the United States.
Esperion announces FDA approval for label expansions of NEXLETOL and NEXLIZET. Photo courtesy of Esperion.
Sheldon Koenig, President and CEO of Esperion, expressed his enthusiasm for the label expansions, stating, “We are pleased to receive approval for our highly anticipated label expansions in the U.S., which will enable more than 70 million patients to now be eligible for NEXLETOL and NEXLIZET.” He emphasized the elimination of the statin use requirement as a critical step in reducing prescribing limitations, positioning NEXLETOL and NEXLIZET as leading non-statin choices within the cardiovascular risk reduction treatment paradigm.
The U.S. approval is based on the groundbreaking CLEAR Outcomes trial, showcasing NEXLETOL’s ability to significantly reduce LDL-C by 20%, hsCRP (a marker of inflammation) by 22%, without elevating glucose levels, and notably reducing the risk of major adverse cardiovascular events (MACE-3) by 15% across the board, and by 39% in primary prevention patients.
With a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP), Esperion anticipates further label expansion in Europe, expecting a final determination by the European Medicines Agency in the upcoming quarter. This global expansion underscores Esperion’s commitment to combating cardiovascular diseases with innovative, accessible treatments.
The FDA’s approval of the expanded labels for NEXLETOL and NEXLIZET represents a transformative moment in the field of cardiovascular disease management and LDL-C lowering. By offering effective non-statin alternatives, Esperion is addressing a critical need for patients seeking different treatment options, thereby enhancing the quality of care and potentially saving lives.