Sanofi Aventis postpones EU application for Multaq

Sanofi-Aventis, the world’s third-largest pharmaceutical company, has withdrawn its marketing application for Multaq, a treatment for atrial fibrillation and flutter.

The company had submitted data for 400mg film-coated Multaq tablets, which contain dronedarone, to the Committee for Medicinal Products for Human Use (CHMP).

However, Sanofi-Aventis’ decision to withdraw its application for Multaq marketing approval follows last week’s decision from the US Food and Drug Administration to issue a “non-approvable” letter

A statement from the company read: “In order to make a more adequate assessment of the benefit-risk balance of the product, the CHMP has requested additional clinical data which cannot be provided within the timeframe of the current procedure.”

Sanofi-Aventis will resubmit new data from the ongoing ATHENA clinical studies to both European and US regulators during 2008.

Last November, the French-based company published clinical trial results which showed that Multaq demonstrated “favourable” tolerability among patients with atrial fibrillation.

Professor Stefan Hohnloser from the department of internal medicine at JW Goethe University in Frankfurt, said that Multaq “may provide an important new treatment approach for atrial fibrillation”.

The current ATHENA trial is designed to assess the morbidity and mortality of atrial fibrillation patients using Multaq.

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