Aceon Gets Coronary Artery Disease Approval Ahead Of Schedule
This article was originally published in The Pink Sheet Daily
Executive Summary
Aceon adds indication for reduction of risk of cardiovascular mortality and non-fatal myocardial infarction in patients with stable coronary artery disease ahead of Sept. 10 user fee date.
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Solvay/CV Therapeutics' ACE inhibitor Aceon (perindopril) received a supplemental approval Aug. 23 for treatment of patients with stable coronary artery disease. FDA approval of the sNDA indicates Aceon for reduction of the risk of cardiovascular mortality and non-fatal myocardial infarction in stable coronary artery disease patients, Solvay said in a same-day release. Aceon was already cleared for treatment of essential hypertension. The approval comes more than a month before the original anticipated action date of Oct. 10; Solvay anticipated a 10-month review when it submitted the sNDA in December. FDA granted the application a six-month priority review, although it later extended that user fee date by three months to Sept. 10 to allow for additional audits of European clinical trial sites (1 (Also see "Aceon User Fee Deadline Extended To Allow For Clinical Trial Site Audits" - Pink Sheet, 20 Jun, 2005.)). The sNDA was supported by data from the 12,000-patient EUROPA (European trial on Reduction Of cardiac events with Perindopril in patients with stable coronary Artery disease) study. The placebo-controlled study, which followed patients for an average of 4.2 years, found a "20% reduction in the combined endpoint of cardiovascular mortality, non-fatal MI and cardiac arrest compared to placebo," according to a release. Under a December 2004 agreement, Solvay will "handle the manufacturing and distribution of the product, and its primary care sales force also continues to promote the product." CVT is responsible for brand marketing and has assembled "a cardiovascular specialty sales force." For these efforts, CVT will "receive a share of sales above a pre-specified baseline." There were no up-front payments associated with the deal. CVT's cardiovascular sales unit will also detail its pending angina treatment Ranexa (ranolazine); the company responded to an "approvable" letter for that product in July (2 (Also see "Ranexa NDA Amendment Seeks Restricted Angina Indication" - Pink Sheet, 28 Jul, 2005.)). - Kathleen Michael |