U.S. FDA Approves Broad New Labels for NEXLETOL and NEXLIZET to Prevent Heart Attacks and Cardiovascular Procedures in Both Primary and Secondary Prevention Patients, Regardless of Statin Use

– New Labels Expand Treatable Population to ~70 Million Patients in U.S. –

– First LDL-C Lowering Non-Statin Indicated for Primary Prevention Patients –

– Approvals Based on Positive CLEAR Outcomes Data and Reflect a Highly Differentiated Product Profile –

– Positive CHMP Opinion Received; European Cardiovascular (CV) Risk Reduction Label Determination Anticipated in Q2 2024 –

– Conference Call and Webcast on Monday, March 25 at 8:00 a.m. ET –

ANN ARBOR, Mich., March 22, 2024 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced that the United States Food and Drug Administration (FDA) has approved broad new label expansions for NEXLETOL (bempedoic acid) Tablets and NEXLIZET (bempedoic acid and ezetimibe) Tablets based on positive CLEAR Outcomes data that include indications for cardiovascular risk reduction and expanded LDL-C lowering in both primary and secondary prevention patients. In addition, the enhanced labels support the use of NEXLETOL and NEXLIZET either alone or in combination with statins. They also include new indications for primary hyperlipidemia, alone or in combination with a statin, and are the only LDL-C lowering non-statin drugs indicated for primary prevention patients.

“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,” said Sheldon Koenig, President and CEO. “Importantly, these approvals expand the accessibility of our highly effective drugs to primary prevention patients, or to those who are at high risk of having a cardiovascular event, but who have not yet had one. These approvals also eliminate the statin use requirement, allowing patients to take NEXLETOL or NEXLIZET either with or without a statin, which significantly reduces previously existing prescribing limitations. We are confident these approvals position NEXLETOL and NEXLIZET as the non-statins of first choice within the cardiovascular risk reduction treatment paradigm.”

“We are thrilled with these significantly expanded labels and look forward to being able to now reach millions more patients with our life-saving drugs. In anticipation of these approvals, we have significantly ramped up our sales force, developed a powerful suite of new promotional materials, created a bold new consumer campaign, enhanced our patient support programs, and continued working with payers to ensure improved patient access.”