FDA accepts NDA for Cardiome/Astellas' vernakalant

US drugmaker Cardiome Pharma and the local unit of Japanese firm Astellas Pharma say that their New Drug Application for the intravenous formulation of vernakalant HCl, an investigational drug for the acute conversion of atrial fibrillation, has been accepted by the Food and Drug Administration.

The NDA for their co-developed drug was submitted in December 2006, and is based on a five-year clinical development program. Upon approval, vernakalant will be marketed in the USA by Astellas Pharma US, under a trade name that has not yet been determined.

In October 2003, Cardiome granted Astellas Pharma US an exclusive license to develop and commercialize intravenous vernakalant in North America. The companies have co-developed vernakalant to the NDA stage, with Astellas responsible for 75% of development costs. Cardiome has retained all rights to the intravenous formulations outside Canada, the USA and Mexico.