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news.The FDA has rejected the heart drug, Multaq, developed by French pharmaceutical giant Sanofi-Aventis, due to insufficient data in the new drug application.
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Multaq is an investigational therapeutic for atrial flutters or fibrillations, a condition that affects approximately $2 million Americans.
The application was made last year and Euroepan regulators are still reviewing the treatment. The drug was rejected because there was not enough data available in the marketing application.
Following the recommendation of the committee the sample size in the trial has been extended from 3700 patients to 4300 patients to attain the planned events rate. Sanofi-Aventis have said that recruitment should be completed by the end of 2006 and they intend to file new data from the US study at the start of 2008.
The primary objective of the study is to assess the efficacy of Multaq in preventing cardiovascular hospitalizations or death, and the secondary objective is to evaluate on a large scale the tolerability of Multaq in the targeted population of patients suffering from the condition.
Atrial flutter or fibrillation is a condition where the upper chambers of the heart beat in an uncoordinated and disorganized fashion resulting in irregular and fast heart rhythm.
Sanofi-Aventis has also recently filed a suit against Amphastar Pharmaceuticals and Teva Pharmaceuticals accusing them of copying their best selling drug, Lovenox.