Merck & Co files MAA for vernakalant IV in Europe for atrial fibrillation

US drug major Merck & Co, which operates in many countries as Merck Sharp & Dohme, says that the European Medicines Agency (EMEA) has accepted for review the company's Marketing Authorization Application regulatory approval of vernakalant intravenous. The proposed indication for vernakalant IV is for the treatment of acute atrial fibrillation, which is the most common cardiac arrhythmia (abnormal heart rhythm).

"Acute atrial fibrillation represents a significant unmet medical need, particularly for older adults," said Stefan Oschmann, president, Europe, Middle East, Africa and Canada, Merck Global Human Health. 'The decision by EMEA to review vernakalant IV represents an important milestone in our long history of developing novel therapeutics for cardiovascular disease,' he noted.

Merck announced a collaboration and licensing agreement with Cardiome Pharma in April for the development and commercialization of vernakalant, which involved an upfront payment of 60 million plus future royalties. The agreement provides the drug major with exclusive global rights to the oral formulation of vernakalant, and its affiliate, MSD Switzerland GmbH, exclusive rights to the IV formulation outside the USA, Canada and Mexico.