Benzinga | Dec 16, 2020 06:28AM EST

Esperion Therapeutics Announced Swiss Approval for First-in-class Cholesterol-lowering Treatment NILEMDO and its Combination with NUSTENDI

Daiichi Sankyo Europe GmbH (hereafter, Daiichi Sankyo') and Esperion Therapeutics (NASDAQ:ESPR) announced today Swissmedic approval for NILEMDO®* (bempedoic acid) tablet and NUSTENDI®* (bempedoic acid and ezetimibe) tablet, offering new treatment options for people with high low-density lipoprotein cholesterol (LDL-C) in Switzerland.

Bempedoic acid is the first oral, once-daily treatment option approved in the last two decades for patients who have difficulty reaching their cholesterol-lowering goals. In a recent observational study, two-thirds of patients in Switzerland with very high cardiovascular risk did not achieve LDL-C target values set out by the European Society of Cardiology.3 Patients who do not reach their LDL-C lowering goals are at increased risk for heart attack and stroke.4 Diagnosis of high cholesterol has increased among older adults in Switzerland in the past 20 years.5

"Cardiovascular disease remains a leading cause of death in Switzerland. In 2017 it accounted for over 30% of deaths across the country, highlighting a critical need for new treatment options for the many people who are having difficulty reaching their LDL-C goals with existing lipid-lowering therapies," said Dr. Lucas Schalch, Country Manager at Daiichi Sankyo Switzerland. "Today's approval of NILEMDO® and NUSTENDI® is a pivotal milestone for patients in secondary prevention, offering them new, convenient treatment options and demonstrating another step forward in our commitment to reduce the risk of atherosclerotic cardiovascular disease."

"Bempedoic acid is a first-in-class adenosine triphosphate-citrate lyase (ACL) inhibitor that lowers LDL-C by inhibiting cholesterol synthesis in the liver. This unique mechanism of action allows it to work alongside existing treatments," said Ashley Hall, Chief Development Officer of Esperion. "Our focus is finding convenient, affordable ways for appropriate patients to manage LDL-C. That is why we also developed a single-tablet combination of bempedoic acid and ezetimibe, to help reduce pill burden."

Bempedoic acid and its fixed combination drug product with ezetimibe were approved in the European Union and the United States earlier this year with different labels and indications.1,6,7,8 In Europe, the products are marketed as NILEMDO® and NUSTENDI®, and in the U.S. as NEXLETOL® and NEXLIZET® (respectively).1,6,7,8 The Esperion team discovered and developed bempedoic acid, drawing on its deep expertise in developing cholesterol-lowering medicines. With strong commercial capabilities, particularly in cardiovascular medicine, Daiichi Sankyo has licensed exclusive commercialization rights to bempedoic acid and the fixed combination drug product of bempedoic acid and ezetimibe in the European Economic Area, Turkey and Switzerland from Esperion. Marketing Authorization for both products in Switzerland will be transferred to Daiichi Sankyo.

Swissmedic approved bempedoic acid for the treatment of adults with clinically manifesting atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolaemia (HeFH) who need additional LDL-C lowering, as an adjunct to diet and in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies.9 The fixed combination drug product of bempedoic acid and ezetimibe is indicated as an adjunct to diet in adults with clinically manifesting ASCVD or HeFH for patients unable to reach LDL-C goals with the maximum tolerated dose of a statin combined with ezetimibe or bempedoic acid, or patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets.10 Both approvals were supported by data from the CLEAR trial program, which included more than 3,600 high- and very-high-risk patients.9,10 The effect of bempedoic acid on cardiovascular morbidity and mortality is currently being investigated in 14,014 patients across 32 countries as part of the CLEAR Outcomes study.11

Bempedoic acid was generally well-tolerated in clinical studies. The most commonly reported adverse reactions with bempedoic acid during pivotal trials were hyperuricaemia, pain in extremity and anaemia. The majority of adverse reactions reported with bempedoic acid were mild to moderate in severity and balanced in occurrence with adverse events in patients receiving placebo.1,6-10