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Kynapid Gets Panel Endorsement For Narrow Approval Due To Small Data Set

Executive Summary

A restricted indication was strongly recommended by Cardiovascular and Renal Drugs Advisory Committee members to offset the uncertainty of adverse events with Astellas/Cardiome's Kynapid (vernakalant), especially since the atrial fibrillation product will likely be used in critical care situations like emergency rooms rather than by specialists

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Narrowing the indication for Cardiome/Astellas' Kynapid (vernakalant) alone was not enough to secure an approval for the atrial fibrillation therapy - Astellas will now run an additional Phase III clinical trial to prospectively study the narrower population that is the new target for approval: patients with recent onset a-fib who do not have a history of heart failure

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