The six month priority review for the supplemental new drug application (sNDA), sets the prescription drug user fee act (PDUFA) date to June 10, 2005. Solvay Pharmaceuticals holds the new drug application for Aceon (perindopril erbumine).
CV Therapeutics and Solvay Pharmaceuticals recently entered into a co- promotion agreement for Aceon, an angiotensin converting enzyme (ACE) inhibitor with tissue activity approved in the US for the treatment of patients with essential hypertension.
Solvay Pharmaceuticals is seeking an expansion of the labeling for Aceon based on the EUROPA study, which 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.
In Europe, perindopril is marketed under the brand name Coversyl and is one of the continent’s leading ACE inhibitors.