“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.

The positive CHMP opinions are based on analyses of the Phase 3 CLEAR (Cholesterol Lowering via Bempedoic Acid, an ATP citrate lyase (ACL)-Inhibiting Regimen) Outcomes trial. The study, involving 13,970 patients across 32 countries, demonstrated a 13% reduction in the relative risk of major adverse cardiovascular events.

The existing label of bempedoic acid (NILEMDO®) provides authorization for adults with primary hypercholesterolemia or mixed dyslipidemia, either in combination with a statin or alone for statin-intolerant patients. The CHMP recommended updating this label to include indication for adults with established or high-risk atherosclerotic cardiovascular disease to reduce cardiovascular risk.

Similarly, the label for bempedoic acid / ezetimibe FDC tablet (NUSTENDI®) is recommended for update to expand its indication to include adults with established or high-risk atherosclerotic cardiovascular disease.

Oliver Appelhans, Head of Europe Specialty Division, Daiichi Sankyo Europe GmbH, commented, “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.”

The European Commission is expected to review the CHMP opinions and deliver its final decision in mid-2024.