The proposed label expansion for Aceon (perindopril erbumine,)an angiotensin converting enzyme (ACE) inhibitor with tissue activity approved in the US for the treatment of patients with essential hypertension, is based on the EUROPA (European trial on reduction of cardiac events with perindopril in patients with stable coronary artery disease) study.
This study assessed the ability of perindopril to reduce cardiovascular mortality, nonfatal myocardial infarction and cardiac arrest in a broad population of patients with stable coronary artery disease, but without heart failure or substantial hypertension.
Solvay Pharmaceuticals holds the new drug application for Aceon and submitted the supplemental new drug application (sNDA) to the FDA on December 10, 2004.