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Bristol-Myers Squibb and Pfizer receive CHMP backing for Eliquis label update
Bristol-Myers Squibb and Pfizer have announced that Europe's Committee for Medicinal Products for Human Use (CHMP) has recommended an update to the label of their drug Eliquis.
The European Medicines Agency committee have endorsed an addition to the current summary of product characteristics, stating that patients can remain on Eliquis while being cardioverted, a procedure to restore normal heart rhythm in patients with arrhythmias, such as atrial fibrillation.
Its positive opinion was based on a post-hoc analysis of the outcomes of the Aristotle study, which demonstrated that the drug can be used safely and effectively in this way.
This will help to make Eliquis a more convenient therapy option for patients with nonvalvular atrial fibrillation (NVAF).
Professor John Camm, clinical cardiologist at St George's Hospital at London, said: "NVAF patients will no longer have to change anticoagulation therapy prior to cardioversion and apixaban therapy can now be continued without interruption."
The drug was previously approved by the UK's National Institute for Health and Clinical Excellence as a means of reducing the risk of stroke and blood clots among atrial fibrillation sufferers last year.
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