An FDA advisory panel voted 10 to 3 in favour of approval for sanofi-aventis’ anti-arrhythmic drug Multaq (dronedarone) on Wednesday, for the treatment of patients with non-permanent atrial fibrillation.

In reference to study data submitted to the agency by the drugmaker, Norman Stockbridge, the director of the FDA’s Cardiovascular & Renal Drugs division, remarked that there was no dispute that Multaq was effective in treating atrial fibrillation by delaying the time of symptom recurrence, “but we have two studies that give different results on mortality and morbidity.”

[ad]

Sanofi-aventis and the FDA agreed that Multaq should not be used by patients with severe heart failure, but the regulator indicated that more information is needed for doctors about how to determine when patients shift from moderate to severe heart failure. Panellists said the company should not be able to claim that Multaq reduced the risk of cardiovascular hospitalisations or death, as sanofi-aventis had proposed based on findings from one study.

The company is seeking approval for Multaq to help restore and maintain normal heart rhythms in patients with atrial fibrillation. A final decision is expected by April 30.

Source: FIrstWord

Popularity: 7% [?]