– Positive CHMP Opinions Are Based On The Analyses Of The Phase 3 Of The CLEAR (Cholesterol Lowering via Bempedoic Acid, an ATP Citrate Lyase (ACL)-Inhibiting Regimen) Outcomes Trial1 –
– European Commission Decision On Label Update Authorization Applications Are Expected To Be Made In 1H 2024 –
ANN ARBOR, Mich. and MUNICH, Germany, March 22, 2024 (GLOBE NEWSWIRE) -- Daiichi Sankyo Europe GmbH (hereafter, ‘Daiichi Sankyo') and Esperion Therapeutics, Inc. jointly announced today, that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted positive opinions for the label update of both bempedoic acid (marketed as NILEMDO®▼) and the bempedoic acid / ezetimibe fixed dose combination (FDC) (marketed as NUSTENDI®▼ ), recommending their approval as treatments to reduce low-density lipoprotein cholesterol (LDL-C) and cardiovascular risk.2 The existing label of bempedoic acid (NILEMDO®▼) provides authorisation for adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:2
- in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin, or2
- alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.2
The CHMP recommended adopting an update to this label, with which bempedoic acid is also indicated in adults with established or at high risk for atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors:2
- in patients on a maximum tolerated dose of a statin with or without ezetimibe, or2
- alone or in combination with ezetimibe in patients who are statin-intolerant, or for whom a statin is contraindicated.2
The existing label of bempedoic acid / ezetimibe FDC tablet (NUSTENDI®▼) provides authorisation of its use in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:2
- in combination with a statin in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin in addition to ezetimibe2, or
- alone in patients who are either statin-intolerant or for whom a statin is contraindicated, and are unable to reach LDL-C goals with ezetimibe alone2,
- in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets with or without statin2.
Additionally, the CHMP recommends an update of the bempedoic acid / ezetimibe label to amend its indication in adults with established or at high risk for atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors2:
- in patients on a maximum tolerated dose of a statin and not adequately controlled with additional ezetimibe treatment2 or,
- in patients who are either statin-intolerant, or for whom a statin is contraindicated, and not adequately controlled with ezetimibe treatment2 or ,
- in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets2.
"The positive CHMP opinion is a crucial milestone towards improved treatment outcomes, as we are now able to address even better the unmet needs of cardiovascular care and prevention among patients in Europe. This first-in-class medicine with proven efficacy in reducing hypercholesterolaemia and preventing cardiovascular risks, is a testament to our tireless efforts to help improve the cardiovascular treatment landscape. The opinion further reinforces our confidence towards continued commitment of supporting clinical communities and healthcare ecosystems across Europe," said Oliver Appelhans, Head of Europe Specialty Division, Daiichi Sankyo Europe GmbH.
"We are thrilled with the positive CHMP opinion, which reflects the significant cardiovascular risk reduction benefit that the bempedoic acid global franchise brings to patients worldwide," said Sheldon Koenig, President and CEO, Esperion. "This latest regulatory milestone further bolsters our efforts to work towards delivering innovative treatment options to manage cardiovascular risk for patients with elevated LDL-C."
The CHMP positive opinions are based on analysis from the Phase 3 CLEAR (Cholesterol Lowering via Bempedoic Acid, an ATP citrate lyase (ACL)-Inhibiting Regimen) Outcomes trial1. The study enrolled a total of 13,970 patients aged 18-85 years old, and took place at 1,250 sites in 32 countries, including 485 sites across Europe1. Results from the Phase 3 CLEAR Outcomes trial demonstrated:
- a 13% reduction in the relative risk of major adverse cardiovascular events defined as a four-component composite of death from cardiovascular (CV) causes, non-fatal myocardial infarction, non-fatal stroke or coronary revascularisation (MACE-4)1.
- Results of the key secondary endpoints and subgroup analyses have been published1.
The CHMP is a scientific committee of the EMA that reviews medical product applications on their scientific and clinical merit. The European Commission will review the CHMP opinions and is expected to deliver its final decision in the mid of the year 2024.