The FDA has approved the oral anticoagulant drug apixaban (Eliquis) to prevent stroke and systemic embolism in patients with nonvalvular atrial fibrillation, the agency announced in a press release.
The oral factor Xa inhibitor also received approval for this indication in Europe, Canada, and Japan in recent weeks.
The U.S. decision comes after results from the ARISTOTLE clinical trial — designed to assess apixaban’s safety and efficacy compared with warfarin — which involved 18,000 patient, showed that those taking apixaban had fewer strokes than those taking warfarin.
“With a population that is living longer, the prevalence of nonvalvular atrial fibrillation is increasing, but many patients are still not being managed effectively with warfarin,” Christopher Granger, MD, study researchers and professor of medicine at Duke University Medical Center in Durham, N.C., said in a press release. “[Apixaban] represents a significant advance over warfarin for health care professionals to reduce the risk of stroke in patients with nonvalvular atrial fibrillation.”
An earlier study comparing apixaban with enoxaparin (Lovenox) in patients with venous thromboembolism failed to show a benefit with apixaban and raised concerns about the potential for increased bleeding risks; although, this risk has not been seen consistently.
Patients with prosthetic heart valves should not take apixaban, nor should patients with atrial fibrillation that is caused by a heart valve problem, the FDA emphasized, as these patients were not studied in clinical trials.
The agency also noted that there is currently no antidote to reverse the drug’s anticoagulant effect should severe bleeding occur.
“Health care professionals should counsel patients on signs and symptoms of possible bleeding,” the FDA said.