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FDA takes Multaq NDA to a panel meeting

This article was originally published in Scrip

Executive Summary

Sanofi-Aventis's amiodarone follow-on drug candidate Multaq (dronedarone) will be taken to a US FDAadvisory panel meeting scheduled for March 18th, the company has confirmed. The product was filed for US and EU approval at the end of June, and was granted priority review status by the FDA at the end of July. Dronedarone has long been in development and in 2006 received a non-approvable letter from the US agency for a filing, based on the ADONIS and EURIDIS studies (which looked at the risk of atrial fibrillation/flutter as the primary endpoint) as well as the earlier ANDROMEDA study which looked at higher-risk patients and was stopped in 2003 on safety concerns. That same year an EU approval application was withdrawn after a request for more data. However, the latest filings are based on the ATHENA study which earlier this year provided more compelling data for the product, showing that it reduced the primary endpoint of cardiovascular hospitalisation and all-cause mortality in atrial fibrillation patients. Dronedarone appears mainly to have a side-effect rather than efficacy advantage over amiodarone but gastrointestinal side-effects could prove a concern (Scrip Online, May 19th, 2008).

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