FDA reviewers give green light for dronedarone

Ahead of Wednesday’s meeting of the Cardiovascular and Renal Advisory Committee meeting, FDA reviewers have recommended approval of Sanofi’s dronedarone to delay recurrence of and hospitalization for atrial fibrillation.

FDA  observers will be pleased to learn that Sanjay Kaul is listed on the roster as a committee member. CardioBrief is willing to bet that Sanjay Kaul will in fact appear as scheduled at this meeting…

(Also on Wednesday, the Circulatory System Devices Panel will meet to discuss the PMA for the  TherOx Aqueous Oxygen System for use in acute myocardial infarction (AMI) patients, who have undergone successful revascularization. Click here for the FDA brieifng documents etc.)

Here’s the chief conclusions of the FDA reviewer (with a strong recommendation from CardioBrief that the FDA hire a copyeditor):

In summary, based on the results of the ADONIS and EURIDIS studies previously reviewed and based on the prevention of hospitalization in the ATHENA study, dronedarone should be approved for the delay recurrence of symptomatic events and decrease hospitalization for atrial fibrillation, in a population likely to have recurrence of AFib. Because of the adverse mortality effect that was observed in the ANDROMEDA study, despite the favorable lean in the ATHENA study, no mortality claim should be granted.

Furthermore, based on the outcome of the ANDROMEDA study individuals with Class III or IV NYHA heart failure should be precluded from its use. The tricky issue is how to control those whose heart failure transitions into NYHA class III from less severe degrees of heart failure.

Here are links to the FDA briefing documents, agenda, meeting roster, and questions:

Notice of Meeting (htm)
Draft Agenda (pdf)
Draft Meeting Roster (pdf)
Briefing Information (htm)
Draft Questions (pdf)


  1. If Multaq & amrodarone are the same, the VA has announced it has amrodarone for VA patients, so we should be able to get amrodarone at VA for A Fib, is that correct?

  2. check walmart and costco on all meds as they may beat the va copay

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