Marketing Application For Vernakalant Intravenous IV Filed In Europe For The Treatment Of Atrial Fibrillation
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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."
Vernakalant is an investigational compound being developed in two formulations, oral and IV, to address multiple unmet needs in the management of atrial fibrillation. Vernakalant IV is being developed for rapid-acting cardioversion, or restoration of normal heart rhythm, of patients suffering from acute atrial fibrillation. Vernakalant oral is being developed for daily maintenance of normal heart rhythm in patients with atrial fibrillation to prevent reoccurrence of atrial fibrillation. Oral vernakalant is currently in Phase II development.
Merck & Co., Inc. announced a collaboration and licensing agreement with Cardiome Pharma Corp. in April for the development and commercialization of vernakalant. The agreement provides Merck & Co., Inc. with exclusive global rights to the oral formulation of vernakalant, and provides the Merck affiliate, MSD Switzerland GmbH, exclusive rights to the I.V. formulation outside of the United States, Canada and Mexico.
About Atrial Fibrillation
Atrial fibrillation (AF) commonly leads to symptoms of fast heart rate or beat, palpitations, shortness of breath and weakness, and an increased risk of developing a blood clot in the heart. If a blood clot in the atria leaves the heart and becomes lodged in an artery in the brain, a stroke may result. About 15 percent of strokes occur in people with AF.
The risk of AF increases with age. The lifetime risk of developing AF at age 55 has been estimated at 24 percent in men and 22 percent in women. In addition, during the past 20 years, there has been a 60% increase in hospital admissions for AF independent of changes in known risk factors.
Merck & Co., Inc.
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