Esperion (NASDAQ: ESPR) announced today that the FDA has approved expanded labels for NEXLETOL® (bempedoic acid) Tablets and NEXLIZET® (bempedoic acid and ezetimibe) Tablets. This approval is based on positive CLEAR Outcomes data and includes indications for cardiovascular risk reduction and increased LDL-C lowering in both primary and secondary prevention patients. The updated labels also support the use of NEXLETOL and NEXLIZET alone or in combination with statins. Furthermore, they introduce new indications for primary hyperlipidemia, either alone or with a statin, making them the only non-statin drugs indicated for lowering LDL-C in primary prevention patients.
Esperion has received FDA approval for expanded labels for NEXLETOL® (bempedoic acid) Tablets and NEXLIZET® (bempedoic acid and ezetimibe) Tablets in the U.S., marking a significant milestone for the company. Sheldon Koenig, President and CEO of Esperion, expressed delight in the approval, emphasizing the broadened accessibility of their drugs to over 70 million eligible patients. These expanded labels now include primary prevention patients and remove the statin use requirement, offering more flexibility in treatment options.
Koenig highlighted the company’s efforts in preparing for these approvals by enhancing sales strategies, promotional materials, consumer campaigns, and patient support programs. He also noted the unique benefits of NEXLETOL and NEXLIZET as once-daily oral medications with reduced side effects compared to statins, making them favorable choices for cardiovascular risk reduction.
Esperion’s pending label expansions in Europe are progressing as planned, with a positive opinion from CHMP received recently. The company expects final approval from the European Medicines Agency in the second quarter of 2024.
The FDA approvals for NEXLIZET and NEXLETOL were based on data from the CLEAR Outcomes trial, demonstrating significant reductions in LDL-C and cardiovascular risk without major adverse effects. This trial showed notable relative risk reductions in various cardiovascular events, further validating the effectiveness and safety profile of these medications.
Esperion is optimistic about the future success of NEXLETOL and NEXLIZET and remains committed to improving patient outcomes in cardiovascular care.
