NICE Issues Favorable Final Draft Guidance On Sanofi-Aventis' Multaq
This article was originally published in The Pink Sheet Daily
Executive Summary
NICE's final appraisal determination on Sanofi-Aventis' Multaq recommends limited use in U.K. atrial fibrillation patients. In France, more favorable ratings by the Transparency Commission might mean a better price.
You may also be interested in...
NICE Accepts Fewer Side Effects In Recommending Sanofi-Aventis's Multaq
Second draft appraisal of Multaq recommends use in atrial fibrillation, even though the drug is less effective than other anti-arrhythmics
Sometimes It Takes Two NDAs For One Approval: Multaq Odyssey Shows FDA In Search Of Reassurance In Tricky Antiarrhythmic Field
FDA approval of Sanofi-Aventis’ Multaq (dronedarone) ultimately required six major clinical trials, four years, two NDAs – one with standard review designation, one with priority – and four separate claims proposed for the indication.
FDA Approves Multaq With REMS, Without Mortality Claim
FDA approves Sanofi-Aventis’ atrial fibrillation drug Multaq with a Risk Evaluation and Mitigation Strategy to ensure the drug is used only in patients whose hearts have returned to normal rhythm.