Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) today announced the filing of a New Drug Submission (NDS) with Health Canada's Therapeutic Products Directorate (TPD) seeking Canadian approval of intravenous vernakalant for the rapid conversion of recent onset atrial fibrillation (AF) to sinus rhythm in adults with AF for up to 7 days. Intravenous vernakalant is commercialized as BRINAVESS® in Europe and elsewhere. Health Canada's TPD will complete a detailed review of the NDS and provide a decision on the approvability of the dossier. Health Canada's target duration of NDS review is 300 days.
Jonathan Mather, Cardiome's Director of Regulatory Affairs said "Cardiome is excited to file this NDS as vernakalant was discovered and developed in Canada, and we believe that Canadians are in need of a novel, atrial selective, rapid acting AF converting agent." William Hunter, MD, President and CEO said, "The filing of this NDS is an important milestone for Cardiome and represents a critical step toward our planned build of Canadian commercial operations during 2016. If it is approved by Health Canada, Cardiome expects to commercialize BRINAVESS using its own Canadian sales force, supported by Cardiome's infrastructure that has commercialized BRINAVESS in many other countries. We expect to further build Canadian commercial operations by licensing or acquiring additional pharmaceuticals for the Canadian market."
Atrial fibrillation affects 350,000 persons per year in Canada.