European Medicines Agency accepts reviewal of Merck's MAA for regulatory approval of vernakalant IV

Aug 27 2009

Merck & Co., Inc., Whitehouse Station, NJ, USA, which operates in many countries as Merck Sharp & Dohme Limited, announced today that the European Medicines Agency (EMEA) accepted for review the Company’s Marketing Authorisation Application (MAA) for regulatory approval of vernakalant intravenous (IV).

The proposed indication for vernakalant IV is for the treatment of acute atrial fibrillation, which is the most common cardiac arrhythmia (abnormal heart rhythm). Atrial fibrillation is the term used to describe an erratic and often rapid heart rate where the electrical activity of the heart's two small upper chambers (atria) is not coordinated, resulting in inefficient pumping of blood and an increased risk of developing a blood clot in the heart, which could lead to stroke.

"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.”