In This Article:
Esperion Therapeutics, Inc. ESPR announced that it has filed new drug submissions (NDSs) in Canada to seek approval for its once-daily, oral non-statin drugs Nexletol (bempedoic acid) and Nexlizet as a treatment to reduce low-density lipoprotein cholesterol or LDL-C (bad cholesterol) and cardiovascular risk.
Nexlizet is a combination of bempedoic acid and ezetimibe.
Shares of the company were up 10.7% on Dec. 2 following the announcement of the news.
ESPR stock has increased 3.6% so far this year against the industry’s decline of 5.2%.
Image Source: Zacks Investment Research
ESPR's Nexletol & Nexlizet Approved in Other Countries
Nexletol and Nexlizet are approved for treating elevated LDL-C and cardiovascular risk reduction in the United States and Europe. The drugs are marketed as Nilemdo and Nustendi in ex-U.S. markets (excluding Japan) in partnership with Daiichi Sankyo.
In March 2024, the FDA approved label expansions for Nexletol tablets and Nexlizet tablets to include indications for cardiovascular risk reduction and expanded LDL-C lowering in both primary and secondary prevention patients – based on positive data from the cardiovascular outcomes study study — CLEAR.
Additionally, the updated labels support the use of Nilemdo and Nustendi either alone or in combination with statins.
The European Commission approved a similar label update for Nilemdo and Nustendi in May 2024.
The inclusion of data from the CLEAR outcomes study in cardiovascular risk reduction has expanded the drugs’ label, allowing them to cater to a larger patient population.
ESPR's Nexletol & Nexlizet Demand Rising
Nexletol and Nexlizet have shown promising uptake since their launch in 2020 in the United States and Europe. Net product sales grew 46.2% year over year during the first nine months of 2024, owing to prescription growth volumes of Nexletol and Nexlizet.
The positive trend is expected to continue in 2025.
Last month, Otsuka Pharmaceutical submitted a new drug application to the Japanese Ministry of Health, Labour and Welfare for the manufacture and sale of bempedoic acid in the country for the treatment of hypercholesterolemia and familial hypercholesterolemia.
Hypercholesterolemia indicates elevated levels of cholesterol in the blood.
Esperion has a collaboration with Otsuka Pharmaceutical for the development and commercialization of Nexletol and Nexlizet tablets in Japan.
Potential approval in additional geographies like Japan and now in Canada is likely to boost sales of the drugs in future quarters.
ESPR's Zacks Rank & Key Picks
Esperion currently carries a Zacks Rank #3 (Hold).