Sanofi-Aventis will resubmit an NDA for Multaq (dronedarone) for the treatment of atrial fibrillation/atrial flutter in 2008 after FDA issued a "non approvable" letter for the medication.

The company announced it had received the letter Aug. 31.

The new filing will include clinical data on the ongoing 12-month follow up trial, ATHENA. The company expects to complete enrollment in the trial by the end of 2006. However, the French drug maker recently expanded the sample size of the trial from 3,700 patients to 4,300 to attain the planned event rates.

The primary endpoint of ATHENA is to assess the efficacy of dronedarone in preventing cardiovascular hospitalizations or death from any cause. The secondary endpoint is the evaluation of large-scale tolerability in patients with atrial fibrillation.

Sanofi's original submission in June 2005 was based on two trials, EURIDIS and ADONIS, which demonstrated that dronedarone reduced a combined endpoint of all-cause hospitalizations or deaths compared to placebo in patients with paroxysmal and persistent atrial fibrillation by 27%.

Adverse event rates in EURIDIS and ADONIS were "generally comparable" to placebo, the company reported last year.

Sanofi has stated that its goal for Multaq is to provide a treatment as effective as or more effective than its Cordarone (licensed to Wyeth) and generics, but with an enhanced tolerability profile. Cordarone (amiodarone) is the gold standard for treatment, but is associated with serious extracardiac side effects.

Multaq had an April user fee date, but that date passed with no comment from Sanofi on the status of the application.

The timing for Sanofi's resubmission could put Cardiome/Astellas' anti-arrhythmic RSD1235 ahead of Multaq. The companies expect to resubmit their NDA for RSD1235 for acute conversion of atrial fibrillation by the end of the year after FDA refused to file the application in May (¹ Also see "FDA Refuses To File Cardiome/Astellas RSD1235 NDA" - Pink Sheet, 31 May, 2006.).

Cardiome/Astellas are also aiming to position their drug as the treatment of choice over Cordarone.

- Jessica Merrill (j.merrill@elsevier.com)

Sanofi Dronedarone Re-Filing Anticipated In 2008 After FDA “Non Approvable” Letter

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