EMA Releases Guideline on Conducting Clinical Trials for Atrial Fibrillation Products

Raps.org: By Alexander Gaffney, 8/15/12
The European Medicines Agency (EMA) has released a new guideline for sponsors of products to prevent strokes in patients with non-valvular atrial fibrillation (AF).

EMA notes the guideline fills a void left by other guidance documents on antiarrhythmics used to prevent AF, which do not address stroke prevention and systemic embolic events (SEE). The new guideline is specifically aimed at assisting sponsors in the clinical testing of such products, regulators said.

Non-valvular AF is characterized by an irregular heartbeat in the absence of rheumatic disease of the heart’s mitral valve or a prosthetically or surgically repaired mitral valve. EMA notes all forms of AF effect approximately 6 million Europeans, with rates expected to double in the next half century. Strokes in those suffering from AF are often fatal, and those who survive are often left more incapacitated than those without AF. Read More