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news.Sanofi has suspended permanent atrial fibrillation outcome study using dronedarone on top of standard therapy (PALLAS) Phase IIIb trial comparing the efficacy of Multaq (dronedarone) 400mg twice-daily to placebo group in patients suffering from permanent atrial fibrillation (AF).
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Following this decision, the investigators of the trial are informed to ask the enrolled patients to stop consuming study medication.
The Phase IIIb trial was a double-blind, placebo-controlled, randomized and multicenter trial and involved around 3,149 patients in the trial.
The patient population included in the PALLAS study is different from the population for which Multaq is currently approved.
Multaq is an antiarrhythmic medication that affects the rhythm of heartbeats and is currently approved in the EU in adult clinically stable patients with a history of, or current non-permanent AF to prevent recurrence of AF or to lower ventricular rate.
McMaster University Division of Cardiology Stuart Connolly said the PALLAS Operations Committee is very disappointed to discover that the hypothesis that dronedarone would improve major outcomes for this high risk patient population has been refuted.
Sanofi chief medical officer Jean-Pierre Lehner said they are notifying regulatory authorities in all countries where the product is approved or under review on this matter.