FDA Approves Aceon to reduce risk of cardiovascular mortality in patients with stable coronary artery disease

Solvay Pharmaceuticals and CV Therapeutics have announced that the U.S. Food and Drug Administration (FDA) has approved Aceon (perindopril erbumine) Tablets for the treatment of patients with stable coronary artery disease to reduce the risk of cardiovascular mortality or non-fatal myocardial infarction (MI). Prior to this labeling expansion, Aceon was indicated for the treatment of essential hypertension.

The new indication is based on the EUROPA (EUropean trial on Reduction Of cardiac events with Perindopril in patients with stable coronary Artery disease) study. EUROPA was a multicenter, randomized, double-blind, placebo-controlled trial in 12,218 patients with stable coronary disease and without heart failure, which assessed the ability of perindopril to reduce cardiovascular death, non-fatal MI or cardiac arrest. Patients had a mean follow-up of 4.2 years.

In this study, in a broad population of patients with stable coronary artery disease, there was a 20 percent reduction in the combined endpoint of cardiovascular mortality, non-fatal MI and cardiac arrest compared to placebo. This significant (p=0.0003) reduction in relative risk was seen in patients on a treatment regimen of 8 mg of perindopril, including patients treated with conventional cardiovascular preventive therapy, such as aspirin, other anti-coagulants, beta-blockers and other anti-hypertensive therapy and lipid lowering therapy, such as statins. Patients not randomized to receive perindopril received placebo in addition to their conventional therapy.

"EUROPA demonstrated that perindopril can provide benefit in stable coronary artery disease patients with or without hypertension and in a broad range of younger and older patients, when used in combination with current conventional therapy," said Kim Fox, M.D., Professor, Royal Brompton Hospital, London, UK and co-chairman of the EUROPA study. "Because of this outcomes benefit, our conclusion was that perindopril should be considered in the management of patients with coronary heart disease."

"The addition of outcomes data to the Aceon labeling was a critical element of the co-promotion opportunity for CV Therapeutics. With this approval, we look forward to launching Aceon, with the expanded indication, to cardiovascular specialists with our newly recruited sales force," said Louis G. Lange, M.D., Ph.D., chairman and chief executive officer of CV Therapeutics.

"The new labeling should allow our combined efforts to maximize the potential for this important product to benefit an expanded group of patients with stable coronary artery disease," said Harold H. Shlevin, Ph.D., president and chief executive officer of Solvay Pharmaceuticals, Inc.

CV Therapeutics and Solvay Pharmaceuticals entered into a co-promotion agreement for Aceon in December 2004. CV Therapeutics is responsible for brand marketing activities and has established a cardiovascular specialty sales force to promote the product. Solvay Pharmaceuticals continues to handle the manufacturing and distribution of the product, and its primary care sales force also continues to promote the product. Solvay Pharmaceuticals books all sales of Aceon and CV Therapeutics will receive a share of sales above a pre-specified baseline. There were no upfront payments by either party associated with the co-promotion agreement.

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