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  • NICE Green Lights New Drug for Atrial Fibrillation

    The UK's cost containment agency, the National Institute for Health and Clinical Excellence (NICE), has issued final guidance recommending  the use of apixaban (Eliquis) by the National Health Service (NHS) for the prevention of stroke. The product received EU-wide marketing approval on 21 November 2012, specifically for the prevention of stroke and systemic embolism in some people with non-valvular atrial fibrillation (AF) with one or more risk factors such as: ...
  • EMA Releases Guideline on Conducting Clinical Trials for Atrial Fibrillation Products

    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-v...