Esperion Files for Canadian Approval of Nexletol and Nexlizet for LDL-C Reduction and Cardiovascular Risk
Key Insights
Esperion (search) has submitted New Drug Submissions (NDSs) in Canada for Nexletol and Nexlizet, seeking approval for LDL-C reduction and cardiovascular risk management.
Nexletol (bempedoic acid) and Nexlizet (bempedoic acid and ezetimibe) are oral, non-statin medications already approved in the United States and Europe.
Heart disease (search) is a leading cause of death in Canada, affecting approximately 2.6 million adults, highlighting the need for new treatment options.
Esperion (search) Therapeutics has announced the submission of New Drug Submissions (NDSs) to Health Canada for Nexletol (bempedoic acid) and Nexlizet (bempedoic acid and ezetimibe), marking a significant step towards expanding the availability of these LDL-C lowering and cardiovascular risk reduction treatments. The filings aim to secure approval for the drugs in the Canadian market, where heart disease (search) remains a major public health concern.
Addressing Cardiovascular Disease in Canada
According to the Public Health Agency of Canada, heart disease (search) is the second leading cause of death in the country, affecting approximately 2.6 million Canadian adults. This underscores the urgent need for effective therapies to manage LDL-C levels and reduce cardiovascular risk in this population.
Nexletol and Nexlizet: Expanding Treatment Options
Nexletol and Nexlizet are oral, non-statin medications already approved in the United States and Europe for reducing LDL-C and cardiovascular risk. Nexlizet is a combination of bempedoic acid and ezetimibe. The recent submissions to Health Canada are based on comprehensive data, including results from the CLEAR outcomes study, which demonstrated the drugs' efficacy in both primary and secondary prevention of cardiovascular events.
The updated labels in the United States and Europe support the use of Nexletol and Nexlizet, either alone or in combination with statins, providing healthcare providers with flexible treatment options to meet individual patient needs.
Clinical Evidence and Label Expansion
The FDA approved label expansions for Nexletol and Nexlizet in March 2024, incorporating data from the CLEAR outcomes study to include indications for cardiovascular risk reduction and expanded LDL-C lowering in both primary and secondary prevention patients. The European Commission followed suit in May 2024 with a similar label update for Nilemdo and Nustendi, the brand names for bempedoic acid and bempedoic acid/ezetimibe combination, respectively, in ex-U.S. markets (excluding Japan).
Esperion's Strategic Partnerships
Esperion (search) has partnered with Daiichi Sankyo to market Nilemdo and Nustendi outside the United States and Japan. Additionally, Otsuka Pharmaceutical has submitted a new drug application to the Japanese Ministry of Health, Labour and Welfare for bempedoic acid, further expanding the potential global reach of the therapy.
Sheldon Koenig, President and CEO of Esperion (search), stated, "These submissions mark another pivotal milestone towards bringing our potentially lifesaving medications to the millions of patients around the world who need it. Heart disease (search) remains the number one cause of death globally, so we look forward to the opportunity to provide NEXLETOL and NEXLIZET as LDL cholesterol lowering and cardiovascular risk reduction treatment options for healthcare providers and patients in Canada."