Cardiome and Astellas to meet with FDA panel over heart drug

The NDA for the intravenous formulation of vernakalant hydrochloride, an investigational new drug for the acute conversion of atrial fibrillation, will be reviewed as part of a two-day meeting regarding therapies for acute conversion of heart arrhythmias.

In preparation for the panel, and at the request of the FDA, Astellas has agreed to file additional information including final safety and efficacy data from the ACT 2 clinical trial, which was ongoing at the time of original NDA submission. As a result of this amendment to the NDA, the FDA has delayed its decision on the drug by three months to January 19, 2008. It is expected that discussions related to the application review and labeling will continue with the FDA throughout the intervening period, the companies said.

The NDA for vernakalant (iv), based on a five-year clinical development program, was submitted in December 2006 and accepted for review by the FDA in February 2007. Upon approval, the drug will be marketed in the US by Astellas Pharma US, an affiliate of Astellas Pharma. In October 2003, Cardiome granted Astellas Pharma US, an exclusive license to develop and commercialize vernakalant (iv) in North America.