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FDA calls for more data on apixaban
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The FDA has said more data are required before approving apixaban for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, according to a press release.
In a complete response letter, the agency requested additional information on data management and verification from the ARISTOTLE trial.
Apixaban (Eliquis, Bristol-Myers Squibb and Pfizer) is not approved for the prevention of stroke or systemic embolism in patients with AF in any country, but has received regulatory approval in the European Union for prevention of venous thromboembolic events in adult patients who have undergone elective hip or knee replacement surgery.
Bristol-Myers Squibb and Pfizer said that they will work closely with the FDA on the appropriate next steps.
“There is a significant unmet need to reduce the risk of stroke in patients with atrial fibrillation," Elliott Sigal, MD, PhD, executive vice president and chief scientific officer of Bristol-Myers Squibb, said in the release. “We believe that the two large trials called ARISTOTLE and AVERROES have established the therapeutic profile for Eliquis and demonstrated a meaningful advance over the standard of care.”