After the presentation and publication of the pivotal ARISTOTLE trial, the novel anticoagulant apixaban (Eliquis, Pfizer and BristolMyers Squibb) was widely expected to be a blockbuster. But then it got bogged down at the FDA where initial hopes for a speedy approval were dashed after highly critical reviews. Ultimately approval of the drug was delayed for 9 months past the original deadline as a result of both a PDUFA date extension and a complete response letter from the FDA. Now an article by Sue Sutter in Pharmaceutical Approvals Monthly, based on documents posted by the FDA on its website, offers an inside look at the drug’s roller coaster ride through the FDA.
The article describes in detail the efforts of the FDA to investigate evidence of fraud and dispensing errors in ARISTOTLE. As Sutter writes: “To many looking in from the outside, the apixaban NDA filing seemed like a sure thing.” Initial results of ARISTOTLE suggested that it had “the potential to be best-in-class if the published ARISTOTLE data were to be believed.”
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Click here to read the full story on Forbes.
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