CHMP Issues Positive Opinions For Both Bempedoic Acid And The Bempedoic Acid / Ezetimibe Fixed-Dose Combination Tablet As Treatments For Hypercholesterolemia And Significantly Reducing Cardiovascular Events - Seite 2

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.