Atrial fibrillation drugs get committee review

Executive Summary

FDA's Cardio-Renal Drugs Advisory Committee will review two new chemical entities for acute conversion of atrial fibrillation Dec. 11-12, Cardiome/Astellas' vernakalant and Solvay's Pulzium (tedisamil), according to Cardiome. The meeting date comes after vernakalant's user fee date, necessitating a three-month user fee extension to Jan. 19. Executives at Cardiome indicated the decision was likely due to the agency's decision to put Solvay's competing product - submitted months after the NDA for vernakalant had been filed - under an advisory committee review. Cardiome submitted its NDA for an intravenous version of vernakalant in December, while Solvay announced its NDA filing for an IV Pulzium formulation in April...