September 21st, 2012
Apixaban (Eliquis) For Atrial Fibrillation Gets Positive European Recommendation
Larry Husten, PHD
The European Committee for Medicinal Products for Human Use (CHMP) has recommended approval for apixaban (Eliquis, Pfizer and BristolMyers Squibb) for atrial fibrillation. The drug is already approved in Europe for the prevention of venous thromboembolic events following hip or knee replacement surgery. The drug has not yet been approved in the United States.
Here is the CHMP-proposed indication for the existing 2.5 mg dose and a new 5 mg dose:
“Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age ≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).”
The CHMP proposed that apixaban should be contraindicated in patients at high risk for major bleeding and in patients receiving other anticoagulants.
The CHMP decision was based on data from the ARISTOTLE and AVERROES pivotal clinical trials.
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