Cardiome/Astellas Kynapid Aiming For Limited Use, With New Trial
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
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