Landmark CLEAR Outcomes Study demonstrates Nexletol tablet is the only LDL-C lowering therapy since statins to reduce hard ischemic events in both primary and secondary prevention patients.- Esperion + Daiichi Sankyo.

The study showed that Nexletol significantly reduced the risk of hard MACE-4 and MACE-3 by 13% and 15%, respectively, and significantly reduced the risk of heart attack and coronary revascularization by 23% and 19%, respectively, as compared to placebo. These results were seen in a broad population of primary and secondary prevention patients who are unable to maximize or tolerate a statin. The proportions of patients experiencing adverse events and serious adverse events were similar between the active and placebo treatment groups. Bempedoic acid (contained in Nexetol and Nexlizet (bempedoic acid and ezetimibe) tablets) now becomes the first LDL-C lowering therapy since statins proven to lower hard ischemic events, not only in those with ASCVD but also in the large number of primary prevention patients for whom limited therapies exist.

The Company believes that it remains on track to submit regulatory filings to the FDA and EMA in 1H 2023. Based on the robustness of the CLEAR Outcomes data, the Company believes it would be entitled to receive $300 million in partner milestone payments upon inclusion of certain required cardiovascular risk reduction data in the EU label, for which payment is tied to the magnitude of the risk percentage reduction included in the label (among other requirements) and ranges from $200 million to $300 million, and up to $140 million in partner milestone payments upon the achievement of other regulatory milestones, including inclusion of certain required cardiovascular risk reduction data in the US label.

“We recognize that physicians and patients are eager for additional non-statin oral treatments that lower LDL-C and hsCRP, do not worsen glucose and reduce major adverse cardiovascular events,” said JoAnne Foody, MD, FACC, FAHA, chief medical officer of Esperion. “As we increasingly move to earlier initiation of lipid lowering therapies to stay ahead of cardiovascular disease, Nexletol and Nexlizet will be integral treatments. These results now position our products as the ‘go-to’ therapies for the large number of primary and secondary prevention patients unable to maximize or tolerate statins to reduce cardiovascular risk. We believe Nexletol and Nexlizet can be next as physicians consider options for further lipid reduction after statins.”

Recently conducted quantitative market research also validates the significant role NEXLETOL and NEXLIZET will have as the preferred next step after statins.

CLEAR Cardiovascular Outcomes Trial : CLEAR Outcomes is a Phase III, event-driven, randomized, multicenter, double-blind, placebo-controlled trial designed to evaluate whether treatment with NexletolL reduces the risk of cardiovascular events in patients with or who are at high risk for cardiovascular disease with documented statin intolerance (inability to tolerate 2 or more statins, one at a low dose) and elevated LDL-C levels (fasting blood LDL-C greater than 100 (2.6 mmol/L)). The study, which includes nearly 14,000 patients at over 1,200 sites in 32 countries, accumulated the targeted 1,620 primary major adverse cardiovascular events (MACE-4) in August 2022.

See-" Bempedoic Acid and Cardiovascular Outcomes in Statin-Intolerant Patients" - Steven E. Nissen, M.D., A. Michael Lincoff, M.D., Danielle Brennan, M.S., Kausik K. Ray, M.D., Denise Mason, B.S.N., John J.P. Kastelein, M.D., et al., for the CLEAR Outcomes Investigators-March 4, 2023.DOI: 10.1056/NEJMoa2215024..