Esperion has announced a pivotal development in cardiovascular treatment, with the FDA approving broad label expansions for NEXLETOL® (bempedoic acid) Tablets and NEXLIZET® (bempedoic acid and ezetimibe) Tablets. This approval, grounded in the positive CLEAR Outcomes data, encompasses indications for cardiovascular risk reduction and expanded LDL-C lowering in both primary and secondary prevention patients. With these enhancements, NEXLETOL and NEXLIZET can be utilized either individually or alongside statins, covering a broad spectrum of patient needs.
This expansion significantly increases the treatable population, now allowing approximately 70 million patients in the U.S. to qualify for treatment with NEXLETOL and NEXLIZET. Notably, these approvals position NEXLETOL and NEXLIZET as the first LDL-C lowering non-statin drugs indicated for primary prevention patients—those at high risk of a cardiovascular event but have not yet experienced one.
Esperion’s CEO, Sheldon Koenig, expressed enthusiasm for these label expansions, highlighting the removal of the statin use requirement as a key factor in widening access to these treatments. This adjustment is expected to streamline the prescription process, making NEXLETOL and NEXLIZET the preferred non-statin options for cardiovascular risk reduction.
In preparation for these approvals, Esperion has significantly expanded its sales force, debuted a robust suite of promotional materials, launched a new consumer campaign, bolstered patient support programs, and worked to enhance patient access through payers. The company anticipates a substantial increase in sales stemming from these strategic initiatives.
NEXLETOL and NEXLIZET are characterized by their once-daily, oral administration, effectiveness in reducing LDL-C and cardiovascular risk, and a side effect profile that notably lacks the common adverse effects associated with statins. This unique positioning, coupled with their approval for use in both primary and secondary prevention patients, marks a significant shift in the landscape of cardiovascular risk reduction.
Esperion is poised for a catalyst-rich year, with future sales expected to surge following these FDA approvals. The company has expressed gratitude to its team for their dedication and efforts in reaching this milestone. Additionally, a positive CHMP Opinion has been received, with a decision on the European cardiovascular risk reduction label anticipated in Q2 2024. Esperion will host a conference call and webcast on Monday, March 25, at 8:00 a.m. ET to further discuss this exciting development.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
