BioCentury
ARTICLE | Regulation

The Kynapid dilemma

January 28, 2008 8:00 AM UTC

The Jan. 19 PDUFA date for Kynapid vernakalant IV from Cardiome Pharma Corp. and Astellas Pharma Inc. came and went without a decision or an extension from FDA. While the agency would not provide any clues, cardiologists are not surprised if the reviewers are having trouble sorting out the complicated issues surrounding the management of atrial fibrillation. The drug does not approach the success rates produced by electrical shock. But it is clear that many practicing physicians would welcome a new drug that converts AF patients to a normal rhythm if it is safer and more efficacious than those currently available.

A healthy heart beats about 60-80 times per minute at rest. During AF, the atria contract irregularly and at rates of more than 300 beats per minute. The irregular rhythm is not passed on to the ventricle, but the heart rate does increase to an unhealthy 110-180 beats per minute...